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FDA 510(k)

DRIED GRAM-NEGATIVE CEFPODOXIME

K-Number: K941030 · 1995-02-16

ApplicantBaxter Diagnostics, Inc.
Decision Date1995-02-16
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DRIED GRAM-NEGATIVE CEFPODOXIME is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-02-16 under 510(k) number K941030. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRIED GRAM-NEGATIVE CEFPODOXIME?

DRIED GRAM-NEGATIVE CEFPODOXIME is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K941030.

When did DRIED GRAM-NEGATIVE CEFPODOXIME receive FDA 510(k) clearance?

DRIED GRAM-NEGATIVE CEFPODOXIME received FDA 510(k) clearance on 1995-02-16, under 510(k) number K941030.

Who is the listed applicant for DRIED GRAM-NEGATIVE CEFPODOXIME?

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

What is the FDA product code for DRIED GRAM-NEGATIVE CEFPODOXIME?

The FDA product code for DRIED GRAM-NEGATIVE CEFPODOXIME is LTT.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK940917LORACARBEF GRAM-NAGATIVE PANELS

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Related Devices (Code: LTT)

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.

K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc.K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc.

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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