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510(k) K982062

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 by Precision Biologicals, Inc. — Product Code GGW

K982062 is an FDA 510(k) premarket notification submitted by Precision Biologicals, Inc. for the device "CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10". The FDA issued a decision of Substantially Equivalent on January 13, 1999. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Precision Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
June 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
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)
  • 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)
  • K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA (July 17, 1997)
  • K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA (July 17, 1997)
  • K951823 — CRYO CHECK LOW FIBRINOGEN CONTROL (January 3, 1996)

Other clearances for product code GGW

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • K090105 — LUPOTEK KCT (December 30, 2010)
  • K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHE (May 8, 2009)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K042762 — PEFAKIT APC-R FACTOR V LEIDEN (December 22, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)
  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (December 23, 1996)
  • K945940 — COATEST(R) APC(TM) RESISTANCE (August 7, 1995)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)

FDA data resources