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Beta/Pak

by Bio/Data Corp.

510(k) K790769Ref 101580

Beta/Pak is a device classified as Class A in the EU and Class II in the US made by Bio/Data Corp., registered in EUDAMED on 27 May 2026 (Basic UDI-DI ++G0561015803Y), cleared under FDA 510(k) K790769 on 3 May 1979 and listed in FDA GUDID since 23 Mar 2022 (UDI-DI *+G0561015801/ $$0100084XXXXX-*), active as of 10 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K790769↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561015803Y Basic UDI-DI *+G0561015801/ $$0100084XXXXX-*UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561015801/ $$0100084XXXXX-* UDI-DI Date23 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK790769 Date3 May 1979ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++G0561015803Y registered 27 May 2026 Active
  • FDA 510(k) K790769 decided 3 May 1979 Active
  • FDA GUDID UDI-DI *+G0561015801/ $$0100084XXXXX-* listed 23 Mar 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K790769
  2. Listed FDA GUDID *+G0561015801/ $$0100084XXXXX-*
  3. Registered EUDAMED ++G0561015803Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
Beta/Pak Combo Kit EUDAMED
BETA/Pak GUDID
Generic name
Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Device name
Beta/Pak Combo Kit (ADP, Collagen, and Ristocetin)
Model / Ref / Catalog
101580
Primary DI / UDI-DI
*+G0561015801/ $$0100084XXXXX-* EUDAMED
G0561015801 GUDID
Basic UDI-DI
++G0561015803Y
510(k) Number
FDA product code
JOZ
EMDN code
W01030199 Haematology reagents - other
GMDN term
Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Device class
Class A EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 864.5700
EU registration type
Standard device
EU market of registration
Italy
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Primary DI / UDI-DIEUDAMED
*+G0561015801/ $$0100084XXXXX-*
510(k)
—
GUDID
G0561015801
Device classEUDAMED
Class A
510(k)
Class II
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561015801/ $$0100084XXXXX-*; FDA GUDID lists G0561015801), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Devices cleared under K790769

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K790769
UDI-DISize and differences
ADP 101312
Bio/Data Corporation
101312 / 101312G0561013121 —On the market
AGG/PAK 5 Combo Kit 107650
Bio/Data Corporation
107650 / 107650G0561076501 —On the market
BETA/Pak 101580
Bio/Data Corporation
101580 / 101580G0561015801 —On the market
Collagen Calf Skin Type 1
Bio/Data Corporation
101562 / Calf Skin Type 1G0561015621 —On the market
Epinephrine 101311
Bio/Data Corporation
101311 / 101311G0561013111 —On the market
PAR/PAK II 101310
Bio/Data Corporation
101310 / 101310G0561013101 —On the market

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Bio/Data Corp.

See all devices from Bio/Data Corp. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)