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FDA 510(k)

HERPES 1 AND 2 MICROASSAYS

K-Number: K871420 · 1987-12-11

ApplicantDiamedix Corp.
Decision Date1987-12-11
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HERPES 1 AND 2 MICROASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1987-12-11 under 510(k) number K871420. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES 1 AND 2 MICROASSAYS?

HERPES 1 AND 2 MICROASSAYS is a medical device that received FDA 510(k) clearance on 1987-12-11. The listed applicant is Diamedix Corp.. The 510(k) number is K871420.

When did HERPES 1 AND 2 MICROASSAYS receive FDA 510(k) clearance?

HERPES 1 AND 2 MICROASSAYS received FDA 510(k) clearance on 1987-12-11, under 510(k) number K871420.

Who is the listed applicant for HERPES 1 AND 2 MICROASSAYS?

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

What is the FDA product code for HERPES 1 AND 2 MICROASSAYS?

The FDA product code for HERPES 1 AND 2 MICROASSAYS is GGC.

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Other records listing Diamedix Corp. as applicant

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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