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FDA 510(k)

GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY

K-Number: K850411 · 1985-05-08

ApplicantWarner-Lambert Co.
Decision Date1985-05-08
Product CodeLGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1985-05-08 under 510(k) number K850411. The device is classified under product code LGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY?

GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY is a medical device that received FDA 510(k) clearance on 1985-05-08. The listed applicant is Warner-Lambert Co.. The 510(k) number is K850411.

When did GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY receive FDA 510(k) clearance?

GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY received FDA 510(k) clearance on 1985-05-08, under 510(k) number K850411.

Who is the listed applicant for GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY?

The FDA product code for GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY is LGP.

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Other records listing Warner-Lambert Co. 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK870584O.P.T.(TM) OVULATION PREDICTION TESTK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK

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Related Devices (Code: LGP)

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.

K864213IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAYInstrumentation Laboratory COK833890COATEST ANTIPLASMINKabivitrum, Inc.K802840ALPHA-ANTIPLASM ASSAYAmerican DadeK803110PROTEOLYTIC ENZYME CONTROLAmerican Dade

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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