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FDA 510(k)

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT

K-Number: K874544 · 1988-08-12

ApplicantMolecular Biosystems, Inc.
Decision Date1988-08-12
Product CodeLGO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Biosystems, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K874544. The device is classified under product code LGO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT?

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Molecular Biosystems, Inc.. The 510(k) number is K874544.

When did SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT receive FDA 510(k) clearance?

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT received FDA 510(k) clearance on 1988-08-12, under 510(k) number K874544.

Who is the listed applicant for SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT?

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

What is the FDA product code for SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT?

The FDA product code for SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT is LGO.

Related Clinical Trials

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.

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Other records listing Molecular Biosystems, 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.

K873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITK873565SNAP(R) ROTAVIRUS DIAGNOSTIC KITK873932THE EXTRACTOR(TM)

Related Devices (Code: LGO)

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.

K894947PLATELIA TOXO IGG KITKallestad Diag, A Div. of Erbamont, Inc.K791118HLA CONTROL SERACalbiochem-Behring Corp.K761009LYMPHOCYTE TYPING, POSITIVE CONTROLHyland Therapeutic Div., Travenol LaboratoriesK761008LYMPHOCYTE TYPING, NEGATIVE CONTROLHyland Therapeutic Div., Travenol Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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