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FDA 510(k)

T-UPTAKE CALIBRATORS

K-Number: K951585 · 1995-06-15

ApplicantDiagnostic Reagents, Inc.
Decision Date1995-06-15
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T-UPTAKE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K951585. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-UPTAKE CALIBRATORS?

T-UPTAKE CALIBRATORS is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K951585.

When did T-UPTAKE CALIBRATORS receive FDA 510(k) clearance?

T-UPTAKE CALIBRATORS received FDA 510(k) clearance on 1995-06-15, under 510(k) number K951585.

Who is the listed applicant for T-UPTAKE CALIBRATORS?

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

What is the FDA product code for T-UPTAKE CALIBRATORS?

The FDA product code for T-UPTAKE CALIBRATORS is JIS.

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Other records listing Diagnostic Reagents, Inc. as applicant

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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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