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Beta/Pak

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K790769

by Bio/Data Corp.

Identity

Trade Name
BETA/Pak FDA UDI
Generic Name
Platelet aggregation study IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
101580 FDA UDI

Identifiers

Catalog Number
101580 FDA UDI
Primary DI / UDI-DI
G0561015801 FDA UDI
510(k) Number
K790769 FDA 510(k)FDA UDI
FDA Product Code
JOZ FDA 510(k)FDA UDI
GMDN Term
Platelet aggregation study IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 864.5700 FDA 510(k)
Regulation Number
864.5700 FDA 510(k)FDA UDI
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Beta/Pak by Bio/Data Corp. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio/Data Corp.

Sources (2)

  • FDA 510(k) K790769 24 fields · synced Jun 18, 2026
  • FDA UDI 9cefe264-a97c-4dd5-87bd-f9b780c243b8 34 fields · synced May 27, 2026