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FDA 510(k)

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)

K-Number: K032518 · 2003-09-15

ApplicantBd Diagnostic Systems
Decision Date2003-09-15
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) 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 2003-09-15 under 510(k) number K032518. 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, GEMIFLOXACIN (STREP)?

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Bd Diagnostic Systems. The 510(k) number is K032518.

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

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) received FDA 510(k) clearance on 2003-09-15, under 510(k) number K032518.

Who is the listed applicant for PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)?

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, GEMIFLOXACIN (STREP)?

The FDA product code for PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) 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 SystemK032153BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/MLK032259PASCO MIC AND MIC/ID PANELSK031429BD 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.

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Official Source

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