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FDA 510(k)

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT

K-Number: K913670 · 1991-12-09

ApplicantThe Binding Site, Ltd.
Decision Date1991-12-09
Product CodeDAB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K913670. The device is classified under product code DAB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAPTOGLOBIN IMMUNOLOGICAL TEST KIT?

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K913670.

When did HAPTOGLOBIN IMMUNOLOGICAL TEST KIT receive FDA 510(k) clearance?

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT received FDA 510(k) clearance on 1991-12-09, under 510(k) number K913670.

Who is the listed applicant for HAPTOGLOBIN IMMUNOLOGICAL TEST KIT?

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

What is the FDA product code for HAPTOGLOBIN IMMUNOLOGICAL TEST KIT?

The FDA product code for HAPTOGLOBIN IMMUNOLOGICAL TEST KIT is DAB.

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Other records listing The Binding Site, Ltd. 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.

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KITK082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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Related Devices (Code: DAB)

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.

K843570FIAX HAPTOGLOBIN TEST KITIntl. Diagnostic TechnologyK772078RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINGelman Instrument Co.

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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