FDA 510(k)

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K-Number: K962150 · 1996-08-16

Decision Date1996-08-16

Product CodeLTT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-08-16 under 510(k) number K962150. 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 AND GRAM-POSITIVE MIC/COMBO PANELS?

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS is a medical device that received FDA 510(k) clearance on 1996-08-16. The listed applicant is Dade Intl., Inc.. The 510(k) number is K962150.

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

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS received FDA 510(k) clearance on 1996-08-16, under 510(k) number K962150.

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

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

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

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

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Other records listing Dade Intl., Inc. as applicant

K974343DADE INNOVIN K970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROL K973668CARDIAC TROPONIN-I (TROP) CALIBRATOR K972524DRIED GRAM-POSITIVE MIC/COMBO PANELS K972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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Related Devices (Code: LTT)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.