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FDA 510(k)

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT

K-Number: K872632 · 1988-02-18

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1988-02-18
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K872632. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT?

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K872632.

When did DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT receive FDA 510(k) clearance?

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT received FDA 510(k) clearance on 1988-02-18, under 510(k) number K872632.

Who is the listed applicant for DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT?

The FDA product code for DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT is GQN.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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Related Devices (Code: GQN)

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.

K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000Diagnostic Hybrids, Inc.K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYLight DiagnosticsK971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, 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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