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FDA 510(k)

AMMONIA/ALCOHOL CONTROL SET

K-Number: K070504 · 2007-04-11

ApplicantPointe Scientific, Inc.,
Decision Date2007-04-11
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA/ALCOHOL CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2007-04-11 under 510(k) number K070504. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA/ALCOHOL CONTROL SET?

AMMONIA/ALCOHOL CONTROL SET is a medical device that received FDA 510(k) clearance on 2007-04-11. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K070504.

When did AMMONIA/ALCOHOL CONTROL SET receive FDA 510(k) clearance?

AMMONIA/ALCOHOL CONTROL SET received FDA 510(k) clearance on 2007-04-11, under 510(k) number K070504.

Who is the listed applicant for AMMONIA/ALCOHOL CONTROL SET?

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

What is the FDA product code for AMMONIA/ALCOHOL CONTROL SET?

The FDA product code for AMMONIA/ALCOHOL CONTROL SET is JJY.

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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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