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FDA 510(k)

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

K-Number: K850682 · 1985-11-25

ApplicantKent Laboratories, Inc.
Decision Date1985-11-25
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL 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 1985-11-25 under 510(k) number K850682. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL?

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K850682.

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

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL received FDA 510(k) clearance on 1985-11-25, under 510(k) number K850682.

Who is the listed applicant for 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL?

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 IMMUNO. TEST HUMAN CERULOPL?

The FDA product code for 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL is DDB.

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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 KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K850686ANTISERUM TO HUMAN PREALBUMIN

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Related Devices (Code: DDB)

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.

K161508CeruloplasminBeckman Coulter Ireland, Inc.K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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