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FDA 510(k)

RADIAL IMMUNO-TEST FOR HUMAN C-REACTI

K-Number: K831958 · 1983-07-19

ApplicantKent Laboratories, Inc.
Decision Date1983-07-19
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAL IMMUNO-TEST FOR HUMAN C-REACTI 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 1983-07-19 under 510(k) number K831958. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAL IMMUNO-TEST FOR HUMAN C-REACTI?

RADIAL IMMUNO-TEST FOR HUMAN C-REACTI is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K831958.

When did RADIAL IMMUNO-TEST FOR HUMAN C-REACTI receive FDA 510(k) clearance?

RADIAL IMMUNO-TEST FOR HUMAN C-REACTI received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831958.

Who is the listed applicant for RADIAL IMMUNO-TEST FOR HUMAN C-REACTI?

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 RADIAL IMMUNO-TEST FOR HUMAN C-REACTI?

The FDA product code for RADIAL IMMUNO-TEST FOR HUMAN C-REACTI is DCK.

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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: DCK)

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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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