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FDA 510(k)

ALCOHOL & AMMONIA CALIBRATOR I

K-Number: K840771 · 1984-04-13

ApplicantAmerican Dade
Decision Date1984-04-13
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALCOHOL & AMMONIA CALIBRATOR I is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K840771. 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 ALCOHOL & AMMONIA CALIBRATOR I?

ALCOHOL & AMMONIA CALIBRATOR I is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is American Dade. The 510(k) number is K840771.

When did ALCOHOL & AMMONIA CALIBRATOR I receive FDA 510(k) clearance?

ALCOHOL & AMMONIA CALIBRATOR I received FDA 510(k) clearance on 1984-04-13, under 510(k) number K840771.

Who is the listed applicant for ALCOHOL & AMMONIA CALIBRATOR I?

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

What is the FDA product code for ALCOHOL & AMMONIA CALIBRATOR I?

The FDA product code for ALCOHOL & AMMONIA CALIBRATOR I is JIT.

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Related Devices (Code: JIT)

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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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