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FDA 510(k)

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT

K-Number: K950102 · 1995-04-10

ApplicantKent Laboratories, Inc.
Decision Date1995-04-10
Product CodeDAY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN C-5 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 1995-04-10 under 510(k) number K950102. The device is classified under product code DAY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN C-5 RADIAL IMMUNODIFFUSION KIT?

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K950102.

When did HUMAN C-5 RADIAL IMMUNODIFFUSION KIT receive FDA 510(k) clearance?

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT received FDA 510(k) clearance on 1995-04-10, under 510(k) number K950102.

Who is the listed applicant for HUMAN C-5 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 C-5 RADIAL IMMUNODIFFUSION KIT?

The FDA product code for HUMAN C-5 RADIAL IMMUNODIFFUSION KIT is DAY.

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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 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: DAY)

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.

K942326HUMAN C5 RID KITSJay H. GellerK772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENTGelman Instrument Co.

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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