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FDA 510(k)

CRYOCHECK LA SURE, MODEL SUR25-10

K-Number: K990580 · 1999-07-28

ApplicantPrecision Biologic
Decision Date1999-07-28
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOCHECK LA SURE, MODEL SUR25-10 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 1999-07-28 under 510(k) number K990580. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCHECK LA SURE, MODEL SUR25-10?

CRYOCHECK LA SURE, MODEL SUR25-10 is a medical device that received FDA 510(k) clearance on 1999-07-28. The listed applicant is Precision Biologic. The 510(k) number is K990580.

When did CRYOCHECK LA SURE, MODEL SUR25-10 receive FDA 510(k) clearance?

CRYOCHECK LA SURE, MODEL SUR25-10 received FDA 510(k) clearance on 1999-07-28, under 510(k) number K990580.

Who is the listed applicant for CRYOCHECK LA SURE, MODEL SUR25-10?

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

What is the FDA product code for CRYOCHECK LA SURE, MODEL SUR25-10?

The FDA product code for CRYOCHECK LA SURE, MODEL SUR25-10 is GIR.

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Other records listing Precision Biologic 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.

K193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIIIK032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLK023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50K023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10

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Related Devices (Code: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)Precision Biologic

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.

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