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FDA 510(k)

ANTISERA TO HUMAN FAB FRAGMENT

K-Number: K771242 · 1977-08-03

ApplicantKent Laboratories, Inc.
Decision Date1977-08-03
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERA TO HUMAN FAB FRAGMENT 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 1977-08-03 under 510(k) number K771242. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERA TO HUMAN FAB FRAGMENT?

ANTISERA TO HUMAN FAB FRAGMENT is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K771242.

When did ANTISERA TO HUMAN FAB FRAGMENT receive FDA 510(k) clearance?

ANTISERA TO HUMAN FAB FRAGMENT received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771242.

Who is the listed applicant for ANTISERA TO HUMAN FAB FRAGMENT?

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 ANTISERA TO HUMAN FAB FRAGMENT?

The FDA product code for ANTISERA TO HUMAN FAB FRAGMENT is DDR.

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Other records listing Kent Laboratories, Inc. as applicant

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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: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

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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