FDA 510(k)

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003

K-Number: K990993 · 1999-06-22

Decision Date1999-06-22

Product CodeJLW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K990993. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003?

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Biocheck, Inc.. The 510(k) number is K990993.

When did BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 receive FDA 510(k) clearance?

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 received FDA 510(k) clearance on 1999-06-22, under 510(k) number K990993.

Who is the listed applicant for BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003?

The FDA 510(k) record lists Biocheck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003?

The FDA product code for BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 is JLW.

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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.