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FDA 510(k)

GEN. DIAG. CHROMOSTRATE REF. PLASMA

K-Number: K850409 · 1985-05-08

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

Device Summary

GEN. DIAG. CHROMOSTRATE REF. PLASMA 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 K850409. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN. DIAG. CHROMOSTRATE REF. PLASMA?

GEN. DIAG. CHROMOSTRATE REF. PLASMA 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 K850409.

When did GEN. DIAG. CHROMOSTRATE REF. PLASMA receive FDA 510(k) clearance?

GEN. DIAG. CHROMOSTRATE REF. PLASMA received FDA 510(k) clearance on 1985-05-08, under 510(k) number K850409.

Who is the listed applicant for GEN. DIAG. CHROMOSTRATE REF. PLASMA?

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 REF. PLASMA?

The FDA product code for GEN. DIAG. CHROMOSTRATE REF. PLASMA is JPA.

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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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