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FDA 510(k)

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K-Number: K972799 · 1997-10-10

ApplicantDade Microscan, Inc.
Decision Date1997-10-10
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DRIED GRAM-POSITIVE MIC/COMBO PANELS 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 1997-10-10 under 510(k) number K972799. 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-POSITIVE MIC/COMBO PANELS?

DRIED GRAM-POSITIVE MIC/COMBO PANELS is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K972799.

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

DRIED GRAM-POSITIVE MIC/COMBO PANELS received FDA 510(k) clearance on 1997-10-10, under 510(k) number K972799.

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

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 DRIED GRAM-POSITIVE MIC/COMBO PANELS?

The FDA product code for DRIED GRAM-POSITIVE MIC/COMBO PANELS is LTT.

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Other records listing Dade Microscan, 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.

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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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