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510(k) K885245

CARY-BLAIR TRANSPORT SYSTEM by Precision Biologicals, Inc. — Product Code JSM

K885245 is an FDA 510(k) premarket notification submitted by Precision Biologicals, Inc. for the device "CARY-BLAIR TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 1989. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Precision Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1989
Date Received
December 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances by Precision Biologicals, Inc.

  • K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5M (January 13, 1999)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5M (January 13, 1999)
  • K971219 — CRYO CHECK INR VALIDATION SET (August 29, 1997)
  • K971222 — CRYO CHECK APC RESISTANT PLASMA (August 19, 1997)
  • K971223 — CRYO CHECK FACTOR V DEFICIENT PLASMA (July 22, 1997)
  • K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMA (July 18, 1997)
  • K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMA (July 18, 1997)
  • K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA (July 17, 1997)
  • K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA (July 17, 1997)

Other clearances for product code JSM

  • K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport De (November 26, 2025)
  • K250205 — Babio® Virus Transport Kit (Non-inactivating) (September 22, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K232565 — UriSponge™ (October 11, 2024)
  • K220908 — Ensol EnTM Specimen Collection and Transport System (August 29, 2024)
  • K240235 — OmniTrans Transport System (August 19, 2024)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K233449 — Avantik VTM (July 15, 2024)
  • K232454 — Viral Transport Media (VTM) (May 3, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)

FDA data resources