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FDA 510(k)

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

K-Number: K951968 · 1995-05-30

ApplicantKent Laboratories, Inc.
Decision Date1995-05-30
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT 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 1995-05-30 under 510(k) number K951968. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN C1Q RADIAL IMMUNODIFFUSION KIT?

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K951968.

When did HUMAN C1Q RADIAL IMMUNODIFFUSION KIT receive FDA 510(k) clearance?

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT received FDA 510(k) clearance on 1995-05-30, under 510(k) number K951968.

Who is the listed applicant for HUMAN C1Q RADIAL IMMUNODIFFUSION KIT?

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 HUMAN C1Q RADIAL IMMUNODIFFUSION KIT?

The FDA product code for HUMAN C1Q RADIAL IMMUNODIFFUSION KIT is DAK.

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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 KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLK850690ANTISERUM TO HUMAN APOLIPOPROTEIN B

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Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K914388C1 RID KITThe Binding Site, Ltd.

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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