FDA 510(k)

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM

K-Number: K043589 · 2005-02-14

Decision Date2005-02-14

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM is the device name listed in this FDA 510(k) record. The listed applicant is Dade Microscan, Inc.. It received FDA 510(k) clearance on 2005-02-14 under 510(k) number K043589. 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 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM?

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM is a medical device that received FDA 510(k) clearance on 2005-02-14. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K043589.

When did MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM receive FDA 510(k) clearance?

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM received FDA 510(k) clearance on 2005-02-14, under 510(k) number K043589.

Who is the listed applicant for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM?

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

What is the FDA product code for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM?

The FDA product code for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM is JWY.

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Other records listing Dade Microscan, Inc. as applicant

K023202MICROSCAN SYNERGIES PLUS K021184MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN K021181MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN K021018MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL K021188MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME K021110MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE

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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.