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FDA 510(k)

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG

K-Number: K935975 · 1994-09-19

ApplicantRemel, Inc.
Decision Date1994-09-19
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 1994-09-19 under 510(k) number K935975. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG?

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG is a medical device that received FDA 510(k) clearance on 1994-09-19. The listed applicant is Remel, Inc.. The 510(k) number is K935975.

When did REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG receive FDA 510(k) clearance?

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG received FDA 510(k) clearance on 1994-09-19, under 510(k) number K935975.

Who is the listed applicant for REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG?

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

What is the FDA product code for REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG?

The FDA product code for REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG is JTN.

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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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