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FDA 510(k)

WELLCOZYME HSV WZO2

K-Number: K875311 · 1988-08-03

ApplicantWellcome Diagnostics
Decision Date1988-08-03
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLCOZYME HSV WZO2 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K875311. 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 WELLCOZYME HSV WZO2?

WELLCOZYME HSV WZO2 is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Wellcome Diagnostics. The 510(k) number is K875311.

When did WELLCOZYME HSV WZO2 receive FDA 510(k) clearance?

WELLCOZYME HSV WZO2 received FDA 510(k) clearance on 1988-08-03, under 510(k) number K875311.

Who is the listed applicant for WELLCOZYME HSV WZO2?

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

What is the FDA product code for WELLCOZYME HSV WZO2?

The FDA product code for WELLCOZYME HSV WZO2 is GQN.

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Other records listing Wellcome Diagnostics 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.

K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K861628WELLCOZYME ROTAVIRUS WZ01K864206REVEAL COLOUR STREP A ZL16

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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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