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FDA 510(k)

ANTISERA TO RABBIT IMMUNOGLOBULIN

K-Number: K790720 · 1979-08-16

ApplicantKent Laboratories, Inc.
Decision Date1979-08-16
Product CodeDFZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERA TO RABBIT IMMUNOGLOBULIN 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 1979-08-16 under 510(k) number K790720. The device is classified under product code DFZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERA TO RABBIT IMMUNOGLOBULIN?

ANTISERA TO RABBIT IMMUNOGLOBULIN is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K790720.

When did ANTISERA TO RABBIT IMMUNOGLOBULIN receive FDA 510(k) clearance?

ANTISERA TO RABBIT IMMUNOGLOBULIN received FDA 510(k) clearance on 1979-08-16, under 510(k) number K790720.

Who is the listed applicant for ANTISERA TO RABBIT IMMUNOGLOBULIN?

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 RABBIT IMMUNOGLOBULIN?

The FDA product code for ANTISERA TO RABBIT IMMUNOGLOBULIN is DFZ.

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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: DFZ)

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.

K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare DiagnosticsK021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERThe Binding Site, Ltd.K020823PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITSanquin Blood Supply FoundationK955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERThe Binding Site, Ltd.K812821H-103 IGG, H-104 IGA, H-105 IGMImmulok, 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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