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FDA 510(k)

RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)

K-Number: K874863 · 1988-02-16

ApplicantMonoclonal Antibodies, Inc.
Decision Date1988-02-16
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) is the device name listed in this FDA 510(k) record. The listed applicant is Monoclonal Antibodies, Inc.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K874863. 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 RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)?

RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K874863.

When did RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) receive FDA 510(k) clearance?

RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) received FDA 510(k) clearance on 1988-02-16, under 510(k) number K874863.

Who is the listed applicant for RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)?

The FDA 510(k) record lists Monoclonal Antibodies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)?

The FDA product code for RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) is GQN.

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Other records listing Monoclonal Antibodies, 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.

K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)K863744HCG CONTROL KITK860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITK854611RAMP URINE HCG ASSAYK850730MODEL SERUM HCG ASSAYK850480OVU STICK SELF-TEST -MODIFICATION

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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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