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FDA 510(k)

LORACARBEF GRAM-NAGATIVE PANELS

K-Number: K940917 · 1995-02-08

ApplicantBaxter Diagnostics, Inc.
Decision Date1995-02-08
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LORACARBEF GRAM-NAGATIVE PANELS 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 1995-02-08 under 510(k) number K940917. 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 LORACARBEF GRAM-NAGATIVE PANELS?

LORACARBEF GRAM-NAGATIVE PANELS is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K940917.

When did LORACARBEF GRAM-NAGATIVE PANELS receive FDA 510(k) clearance?

LORACARBEF GRAM-NAGATIVE PANELS received FDA 510(k) clearance on 1995-02-08, under 510(k) number K940917.

Who is the listed applicant for LORACARBEF GRAM-NAGATIVE PANELS?

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 LORACARBEF GRAM-NAGATIVE PANELS?

The FDA product code for LORACARBEF GRAM-NAGATIVE PANELS is JWY.

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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 PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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.

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