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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Precision Biologicals, Inc. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

139 daysmedian FDA review time
287 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10Precision Biologicals, Inc.1999-01-132120
K981174CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0MLPrecision Biologicals, Inc.1999-01-132870
K981173CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OMLPrecision Biologicals, Inc.1999-01-132870
K971219CRYO CHECK INR VALIDATION SETPrecision Biologicals, Inc.1997-08-291490
K971222CRYO CHECK APC RESISTANT PLASMAPrecision Biologicals, Inc.1997-08-191390
K971223CRYO CHECK FACTOR V DEFICIENT PLASMAPrecision Biologicals, Inc.1997-07-221110
K971227CRYO CHECK FACTOR X DEFICIENT PLASMAPrecision Biologicals, Inc.1997-07-181070
K971226CRYO CHECK FACTOR IX DEFICIENT PLASMAPrecision Biologicals, Inc.1997-07-181070
K971225CRYO CHECK FACTOR VIII DEFICIENT PLASMAPrecision Biologicals, Inc.1997-07-171060
K971224CRYO CHECK FACTOR VII DEFICIENT PLASMAPrecision Biologicals, Inc.1997-07-171060
K951823CRYO CHECK LOW FIBRINOGEN CONTROLPrecision Biologicals, Inc.1996-01-032580
K952623CRYO CHECK LUPUS PLASMAPrecision Biologicals, Inc.1995-11-061510
K952624CRYO CHECK ABNORMAL REFERENCE CHECK I & IIPrecision Biologicals, Inc.1995-10-301440
K952622CRYO CHECK NORMAL HUMAN REFERENCE PLASMAPrecision Biologicals, Inc.1995-10-301440
K922887CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEMPrecision Biologicals, Inc.1993-02-252540
K885245CARY-BLAIR TRANSPORT SYSTEMPrecision Biologicals, Inc.1989-03-21890
K885244SAF FECAL COLLECTION KITPrecision Biologicals, Inc.1989-03-21890
K884854COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)Precision Biologicals, Inc.1989-01-30730
K884855THROMBOPLASTINPrecision Biologicals, Inc.1989-01-30730
K884856APTT REAGENTPrecision Biologicals, Inc.1989-01-30730

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda