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FDA 510(k)

ETEST FOR AMPICILLIN/SULBACTAM 2/1

K-Number: K935519 · 1994-11-04

ApplicantAb Biodisk North America, Inc.
Decision Date1994-11-04
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST FOR AMPICILLIN/SULBACTAM 2/1 is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk North America, Inc.. It received FDA 510(k) clearance on 1994-11-04 under 510(k) number K935519. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST FOR AMPICILLIN/SULBACTAM 2/1?

ETEST FOR AMPICILLIN/SULBACTAM 2/1 is a medical device that received FDA 510(k) clearance on 1994-11-04. The listed applicant is Ab Biodisk North America, Inc.. The 510(k) number is K935519.

When did ETEST FOR AMPICILLIN/SULBACTAM 2/1 receive FDA 510(k) clearance?

ETEST FOR AMPICILLIN/SULBACTAM 2/1 received FDA 510(k) clearance on 1994-11-04, under 510(k) number K935519.

Who is the listed applicant for ETEST FOR AMPICILLIN/SULBACTAM 2/1?

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

What is the FDA product code for ETEST FOR AMPICILLIN/SULBACTAM 2/1?

The FDA product code for ETEST FOR AMPICILLIN/SULBACTAM 2/1 is JWY.

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Other records listing Ab Biodisk North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JWY)

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K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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