Company · CA

Precision Biologicals, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1999. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GJT	Plasma, Coagulation Factor Deficient	7
GGN	Plasma, Coagulation Control	6
GGC	Control, Plasma, Abnormal	2
JSM	Culture Media, Non-Propagating Transport	2
GFO	Activated Partial Thromboplastin	1
GGW	Test, Time, Partial Thromboplastin	1
GJS	Test, Time, Prothrombin	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jan 13, 1999	K982062	CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 Precision Biologicals, Inc., CA	GGW
Jan 13, 1999	K981174	CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) Precision Biologicals, Inc., CA	GJT
Jan 13, 1999	K981173	CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) Precision Biologicals, Inc., CA	GJT
Aug 29, 1997	K971219	CRYO CHECK INR VALIDATION SET Precision Biologicals, Inc., CA	GGN
Aug 19, 1997	K971222	CRYO CHECK APC RESISTANT PLASMA Precision Biologicals, Inc., CA	GGN
Jul 22, 1997	K971223	CRYO CHECK FACTOR V DEFICIENT PLASMA Precision Biologicals, Inc., CA	GJT
Jul 18, 1997	K971227	CRYO CHECK FACTOR X DEFICIENT PLASMA Precision Biologicals, Inc., CA	GJT
Jul 18, 1997	K971226	CRYO CHECK FACTOR IX DEFICIENT PLASMA Precision Biologicals, Inc., CA	GJT
Jul 17, 1997	K971225	CRYO CHECK FACTOR VIII DEFICIENT PLASMA Precision Biologicals, Inc., CA	GJT
Jul 17, 1997	K971224	CRYO CHECK FACTOR VII DEFICIENT PLASMA Precision Biologicals, Inc., CA	GJT
Jan 3, 1996	K951823	CRYO CHECK LOW FIBRINOGEN CONTROL Precision Biologicals, Inc., CA	GGN
Nov 6, 1995	K952623	CRYO CHECK LUPUS PLASMA Precision Biologicals, Inc., CA	GGC
Oct 30, 1995	K952624	CRYO CHECK ABNORMAL REFERENCE CHECK I & II Precision Biologicals, Inc., CA	GGC
Oct 30, 1995	K952622	CRYO CHECK NORMAL HUMAN REFERENCE PLASMA Precision Biologicals, Inc., CA	GGN
Feb 25, 1993	K922887	CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM Precision Biologicals, Inc., CA	GGN
Mar 21, 1989	K885245	CARY-BLAIR TRANSPORT SYSTEM Precision Biologicals, Inc., CA	JSM
Mar 21, 1989	K885244	SAF FECAL COLLECTION KIT Precision Biologicals, Inc., CA	JSM
Jan 30, 1989	K884856	APTT REAGENT Precision Biologicals, Inc., CA	GFO
Jan 30, 1989	K884855	THROMBOPLASTIN Precision Biologicals, Inc., CA	GJS
Jan 30, 1989	K884854	COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) Precision Biologicals, Inc., CA	GGN

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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