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FDA 510(k)

GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)

K-Number: K812078 · 1981-07-23

ApplicantAbbott Laboratories
Decision Date1981-07-23
Product CodeJTY
Advisory CommitteeMI
DecisionUnknown

Device Summary

GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K812078. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)?

GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Abbott Laboratories. The 510(k) number is K812078.

When did GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) receive FDA 510(k) clearance?

GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) received FDA 510(k) clearance on 1981-07-23, under 510(k) number K812078.

Who is the listed applicant for GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)?

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

What is the FDA product code for GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)?

The FDA product code for GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) is JTY.

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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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