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FDA 510(k)

SEROCARD HSV IGG ANTIBODY TEST KIT

K-Number: K903070 · 1990-08-09

ApplicantDisease Detection International, Inc.
Decision Date1990-08-09
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROCARD HSV IGG ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K903070. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEROCARD HSV IGG ANTIBODY TEST KIT?

SEROCARD HSV IGG ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K903070.

When did SEROCARD HSV IGG ANTIBODY TEST KIT receive FDA 510(k) clearance?

SEROCARD HSV IGG ANTIBODY TEST KIT received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903070.

Who is the listed applicant for SEROCARD HSV IGG ANTIBODY TEST KIT?

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

What is the FDA product code for SEROCARD HSV IGG ANTIBODY TEST KIT?

The FDA product code for SEROCARD HSV IGG ANTIBODY TEST KIT is LGC.

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Other records listing Disease Detection International, Inc. as applicant

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K943252PRO-STEP LH OVULATION PREDICTION TESTK925303PRO-STEP PT HCGK925125PRO-STEP HCGK911826IMMUNOCARD HCG ONE STEP (I-S) TEST KITK902571MODIFICATION OF SEROCARD RUBELLA IGG TESTK895912IMMUNOCARD HCG II-S TEST KIT

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Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.

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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