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FDA 510(k)

MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.

K-Number: K884761 · 1988-12-05

ApplicantDifco Laboratories, Inc.
Decision Date1988-12-05
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K884761. 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 MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.?

MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K884761.

When did MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. receive FDA 510(k) clearance?

MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. received FDA 510(k) clearance on 1988-12-05, under 510(k) number K884761.

Who is the listed applicant for MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.?

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

What is the FDA product code for MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.?

The FDA product code for MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. is GQN.

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Related Devices (Code: GQN)

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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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