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FDA 510(k)

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2

K-Number: K850683 · 1985-11-27

ApplicantKent Laboratories, Inc.
Decision Date1985-11-27
Product CodeDEB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-27 under 510(k) number K850683. 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 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2?

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 is a medical device that received FDA 510(k) clearance on 1985-11-27. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K850683.

When did 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 receive FDA 510(k) clearance?

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 received FDA 510(k) clearance on 1985-11-27, under 510(k) number K850683.

Who is the listed applicant for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2?

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

What is the FDA product code for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2?

The FDA product code for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 is DEB.

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Other records listing Kent Laboratories, 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLK850686ANTISERUM TO HUMAN PREALBUMIN

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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.K914389ALPHA-2 MACROGLOBULIN TEST RID KITThe Binding Site, Ltd.K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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