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FDA 510(k)

ALPHA-2 MACROGLOBULIN TEST RID KIT

K-Number: K914389 · 1991-12-20

ApplicantThe Binding Site, Ltd.
Decision Date1991-12-20
Product CodeDEB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPHA-2 MACROGLOBULIN TEST RID 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 1991-12-20 under 510(k) number K914389. The device is classified under product code DEB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-2 MACROGLOBULIN TEST RID KIT?

ALPHA-2 MACROGLOBULIN TEST RID KIT is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K914389.

When did ALPHA-2 MACROGLOBULIN TEST RID KIT receive FDA 510(k) clearance?

ALPHA-2 MACROGLOBULIN TEST RID KIT received FDA 510(k) clearance on 1991-12-20, under 510(k) number K914389.

Who is the listed applicant for ALPHA-2 MACROGLOBULIN TEST RID 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 ALPHA-2 MACROGLOBULIN TEST RID KIT?

The FDA product code for ALPHA-2 MACROGLOBULIN TEST RID KIT is DEB.

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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: DEB)

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.

K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMDade Behring, Inc.K053073N ANTISERA TO HUMAN ALPHA2-MACROGLOBULINDade Behring, Inc.K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTBeckman Instruments, Inc.K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2Kent Laboratories, Inc.K851282RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULICooper Biomedical, 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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