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FDA 510(k)

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE

K-Number: K970473 · 1997-05-01

ApplicantAb Biodisk
Decision Date1997-05-01
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1997-05-01 under 510(k) number K970473. 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 SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE?

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE is a medical device that received FDA 510(k) clearance on 1997-05-01. The listed applicant is Ab Biodisk. The 510(k) number is K970473.

When did ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE receive FDA 510(k) clearance?

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE received FDA 510(k) clearance on 1997-05-01, under 510(k) number K970473.

Who is the listed applicant for ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE?

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

What is the FDA product code for ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE?

The FDA product code for ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE is JWY.

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Other records listing Ab Biodisk 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.

K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLK052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAK042392DAPTOMYCINK042390ETEST FOR GEMIFLOXACINK040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

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Related Devices (Code: JWY)

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.

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

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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