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FDA 510(k)

ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870

K-Number: K851278 · 1985-04-17

ApplicantStanbio Laboratory
Decision Date1985-04-17
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1985-04-17 under 510(k) number K851278. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870?

ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 is a medical device that received FDA 510(k) clearance on 1985-04-17. The listed applicant is Stanbio Laboratory. The 510(k) number is K851278.

When did ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 receive FDA 510(k) clearance?

ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 received FDA 510(k) clearance on 1985-04-17, under 510(k) number K851278.

Who is the listed applicant for ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870?

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

What is the FDA product code for ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870?

The FDA product code for ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 is LDP.

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Related Devices (Code: LDP)

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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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