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FDA 510(k)

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB

K-Number: K831957 · 1983-07-18

ApplicantKent Laboratories, Inc.
Decision Date1983-07-18
Product CodeDAD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB 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 1983-07-18 under 510(k) number K831957. The device is classified under product code DAD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB?

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K831957.

When did DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB receive FDA 510(k) clearance?

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831957.

Who is the listed applicant for DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB?

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 DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB?

The FDA product code for DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB is DAD.

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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 KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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Related Devices (Code: DAD)

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.

K993480K-ASSAY HAPTOGLOBINKamiya Biomedical Co.K972639TINA-QUANT HAPTOGLOBINBoehringer Mannheim Corp.K964301N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTBeckman Instruments, Inc.K952593N/T PROTEIN CONTROL SY/L, M AND HBehring Diagnostics, Inc.K915829IL TEST(TM) HAPTOGLOBIN (HPT)Instrumentation Laboratory 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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