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Cyto-Chex Bct

by Streck

510(k) K080552

Cyto-Chex Bct is a Class II device made by Streck, cleared under FDA 510(k) K080552 on 31 Jul 2008, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080552 Date31 Jul 2008ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1684-2017 FDA Class II initiated 23 Feb 2017

    Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

Timeline

2 dated events

  1. Cleared FDA 510(k) K080552
  2. Recall initiated FDA recalls Z-1684-2017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GIM
Device class
Class II
Regulation
21 CFR Part 862.1675
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K080552

11 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 K080552
UDI-DISize and differences
Cyto-Chex BCT 213361
Streck
213361 / 21336110844509000829
Total Volume 5.0 mL
On the market
Cyto-Chex BCT 213362
Streck
213362 / 21336220844509000826
Total Volume 5.0 mL
On the market
Cyto-Chex BCT 213386
Streck
213386 / 21338630844509000823
Total Volume 5.0 mL
On the market
Cyto-Chex BCT 213559
Streck
213559 / 21355910844509000836
Total Volume 2.0 mL
On the market
Cyto-Chex BCT 218980
Streck
218980 / 21898020844509000833
Total Volume 2.0 mL
On the market
Cyto-Chex BCT 230304
Streck
230304 / 23030410844509002205
Total Volume 4.0 mL
On the market
Cyto-Chex BCT 230305
Streck
230305 / 23030520844509002202
Total Volume 4.0 mL
On the market
Cyto-Chex BCT 230306
Streck
230306 / 23030630844509002209
Total Volume 4.0 mL
On the market
Cyto-Chex BCT 230353
Streck
230353 / 23035340844509002206
Total Volume 4.0 mL
On the market
Cyto-Chex® BCT 230376
Streck
230376 / 23037630844509000830
Total Volume 2.0 mL
On the market
Cyto-Chex® BCT 230377
Streck
230377 / 23037740844509000837
Total Volume 2.0 mL
On the market

Similar devices

Other devices filed under FDA product code GIM (Tubes, Vacuum Sample, With Anticoagulant).

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