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FDA 510(k)

COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.

K-Number: K895649 · 1990-01-18

ApplicantVentrex Laboratories, Inc.
Decision Date1990-01-18
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex Laboratories, Inc.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K895649. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.?

COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Ventrex Laboratories, Inc.. The 510(k) number is K895649.

When did COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. receive FDA 510(k) clearance?

COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. received FDA 510(k) clearance on 1990-01-18, under 510(k) number K895649.

Who is the listed applicant for COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.?

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

What is the FDA product code for COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.?

The FDA product code for COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. is JIT.

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Other records listing Ventrex 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.

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Related Devices (Code: JIT)

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.

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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.

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