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FDA 510(k)

ANTISERUM, HUMAN, IGG H & L CHAIN

K-Number: K790702 · 1979-09-04

ApplicantKent Laboratories, Inc.
Decision Date1979-09-04
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM, HUMAN, IGG H & L CHAIN 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 1979-09-04 under 510(k) number K790702. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM, HUMAN, IGG H & L CHAIN?

ANTISERUM, HUMAN, IGG H & L CHAIN is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K790702.

When did ANTISERUM, HUMAN, IGG H & L CHAIN receive FDA 510(k) clearance?

ANTISERUM, HUMAN, IGG H & L CHAIN received FDA 510(k) clearance on 1979-09-04, under 510(k) number K790702.

Who is the listed applicant for ANTISERUM, HUMAN, IGG H & L CHAIN?

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 ANTISERUM, HUMAN, IGG H & L CHAIN?

The FDA product code for ANTISERUM, HUMAN, IGG H & L CHAIN is DEW.

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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: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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