Atlas FDA

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN

FDA 510(k) clearance K020626 · decided 2002-04-26

Clearance details

K-number
K020626
Device name
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
Applicant
Dade Microscan, Inc.
Decision
Substantially Equivalent
Date received
2002-02-26
Decision date
2002-04-26
Days to decision
59 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

+ Add to Predicate Builder ◉ Watch Dade Microscan

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
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

RecordFirmDate
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panel recall (Z-0108-2016)Beckman Coulter Inc.2015-10-07
MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panel recall (Z-0109-2016)Beckman Coulter Inc.2015-10-07