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FDA 510(k)

GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY

K-Number: K850410 · 1985-05-08

ApplicantWarner-Lambert Co.
Decision Date1985-05-08
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GEN. DIAG. CHROMOSTRATE PLASMINOGEN 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 K850410. The device is classified under product code DDX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY?

GEN. DIAG. CHROMOSTRATE PLASMINOGEN 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 K850410.

When did GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY receive FDA 510(k) clearance?

GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY received FDA 510(k) clearance on 1985-05-08, under 510(k) number K850410.

Who is the listed applicant for GEN. DIAG. CHROMOSTRATE PLASMINOGEN 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 PLASMINOGEN ASSAY?

The FDA product code for GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY is DDX.

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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: DDX)

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.

K941346PLASMINOGEN RID TEST KITThe Binding Site, Ltd.K884766BERICHROM(R) PLASMINOGENBehring Diagnostics, Inc.K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory COK854572COATEST PLASMINOGENKabivitrum, Inc.K832591DIACROM *PLGWellcome DiagnosticsK812625ACA PLASMINOGEN TEST PACKE.I. Dupont DE Nemours & Co., Inc.

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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