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FDA 510(k)

ACA PLUS FT4 CALIBRATOR

K-Number: K962594 · 1996-08-15

ApplicantDade Intl., Inc.
Decision Date1996-08-15
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA PLUS FT4 CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962594. 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 ACA PLUS FT4 CALIBRATOR?

ACA PLUS FT4 CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Dade Intl., Inc.. The 510(k) number is K962594.

When did ACA PLUS FT4 CALIBRATOR receive FDA 510(k) clearance?

ACA PLUS FT4 CALIBRATOR received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962594.

Who is the listed applicant for ACA PLUS FT4 CALIBRATOR?

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

What is the FDA product code for ACA PLUS FT4 CALIBRATOR?

The FDA product code for ACA PLUS FT4 CALIBRATOR is JIT.

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Other records listing Dade Intl., 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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