MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

FDA 510(k) clearance K131275 · decided 2013-11-08

Clearance details

K-number: K131275
Device name: MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
Applicant: Siemens Helathcare Diagnostics, Inc.
Decision: Substantially Equivalent
Date received: 2013-05-03
Decision date: 2013-11-08
Days to decision: 189 days
Clearance type: Traditional
Product code: LTT
Device class: 2
Regulation number: 866.1640
Medical specialty: Microbiology
Advisory committee: Microbiology
Location: West Sacramento, CA, US
Third-party review: No
Expedited review: No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804)	Beckman Coulter, Inc.	2025-08-20
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036)	Beckman Coulter, Inc.	2025-08-15
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084)	Beckman Coulter, Inc.	2025-07-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343)	Beckman Coulter, Inc.	2020-11-16
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K201423)	Beckman Coulter, Inc.	2020-06-29
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) (K193536)	Beckman Coulter, Inc.	2020-03-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) (K193358)	Beckman Coulter, Inc.	2020-03-03
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) (K183127)	Beckman Coulter, Inc.	2019-02-12
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (K172337)	Beckman Coulter, Inc.	2017-12-15
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (K172912)	Beckman Coulter, Inc.	2017-12-07
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (K172255)	Beckman Coulter, Inc.	2017-12-01
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (K162740)	Beckman Coulter, Inc.	2017-03-21

Recalls involving this device

No recalls on record reference this clearance.