Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APTT REAGENT

K-Number: K884856 · 1989-01-30

ApplicantPrecision Biologicals, Inc.
Decision Date1989-01-30
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

APTT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologicals, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884856. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTT REAGENT?

APTT REAGENT is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K884856.

When did APTT REAGENT receive FDA 510(k) clearance?

APTT REAGENT received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884856.

Who is the listed applicant for APTT REAGENT?

The FDA 510(k) record lists Precision Biologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTT REAGENT?

The FDA product code for APTT REAGENT is GFO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Precision Biologicals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981173CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)K981174CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10K971219CRYO CHECK INR VALIDATION SETK971222CRYO CHECK APC RESISTANT PLASMAK971223CRYO CHECK FACTOR V DEFICIENT PLASMA

View all 20 devices →

Related Devices (Code: GFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑