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FDA 510(k)

BACTIGEN SALMONELLA-SHIGELLA TEST

K-Number: K870813 · 1987-04-22

ApplicantArmkel, LLC
Decision Date1987-04-22
Product CodeGRM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN SALMONELLA-SHIGELLA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K870813. The device is classified under product code GRM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIGEN SALMONELLA-SHIGELLA TEST?

BACTIGEN SALMONELLA-SHIGELLA TEST is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Armkel, LLC. The 510(k) number is K870813.

When did BACTIGEN SALMONELLA-SHIGELLA TEST receive FDA 510(k) clearance?

BACTIGEN SALMONELLA-SHIGELLA TEST received FDA 510(k) clearance on 1987-04-22, under 510(k) number K870813.

Who is the listed applicant for BACTIGEN SALMONELLA-SHIGELLA TEST?

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

What is the FDA product code for BACTIGEN SALMONELLA-SHIGELLA TEST?

The FDA product code for BACTIGEN SALMONELLA-SHIGELLA TEST is GRM.

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Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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Related Devices (Code: GRM)

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.

K961957SAS SALMONELLA H Z4, Z32 ANTISERUMSa Scientific, Inc.K961953SAS SALMONELA H Z24 ANTISERUMSa Scientific, Inc.K961952SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMSSa Scientific, Inc.K961955SAS SALMONELLA H Z42 ANTISERUMSa Scientific, Inc.K961966SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUMSa Scientific, Inc.K961961SAS SALMONELLA H F,G,T ANTISERUMSa Scientific, 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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