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FDA 510(k)

PASCO MIC AND MIC/ID PANELS

K-Number: K032259 · 2003-08-19

ApplicantBd Diagnostic Systems
Decision Date2003-08-19
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PASCO MIC AND MIC/ID PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Bd Diagnostic Systems. It received FDA 510(k) clearance on 2003-08-19 under 510(k) number K032259. 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 PASCO MIC AND MIC/ID PANELS?

PASCO MIC AND MIC/ID PANELS is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Bd Diagnostic Systems. The 510(k) number is K032259.

When did PASCO MIC AND MIC/ID PANELS receive FDA 510(k) clearance?

PASCO MIC AND MIC/ID PANELS received FDA 510(k) clearance on 2003-08-19, under 510(k) number K032259.

Who is the listed applicant for PASCO MIC AND MIC/ID PANELS?

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

What is the FDA product code for PASCO MIC AND MIC/ID PANELS?

The FDA product code for PASCO MIC AND MIC/ID PANELS is JWY.

Related Clinical Trials

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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Other records listing Bd Diagnostic Systems 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.

K260213BD BACTEC FXI Culture SystemK032518PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)K032153BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/MLK031429BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/MLK030091BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML

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

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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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