Atlas FDA

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS

FDA 510(k) clearance K870074 · decided 1987-04-14

Clearance details

K-number
K870074
Device name
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
Applicant
Microscan Div. Baxter Healthcare Corp.
Decision
Substantially Equivalent
Date received
1987-01-08
Decision date
1987-04-14
Days to decision
96 days
Clearance type
Traditional
Product code
JWY
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 Microscan Div. Baxter Healthcare Corp.

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
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447)bioMérieux SA2026-04-21
MTS Gepotidacin 0.016-256 µg/mL (K260696)Liofilchem s.r.l.2026-04-17
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (K252114)Liofilchem s.r.l.2025-10-02
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062)Thermo Fisher Scientific2025-09-25
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575)Thermo Fisher Scientific2025-09-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)Thermo Fisher Scientific2025-08-28
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (K251580)Liofilchem s.r.l.2025-08-20
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990)Thermo Fisher Scientific2025-06-30
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843)Thermo Fisher Scientific2025-06-20
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)Biomérieux2025-06-12
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659)Thermo Fisher Scientific2025-05-22
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274)Biomerieux S.A.2025-04-30

Recalls involving this device

RecordFirmDate
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 recall (Z-1524-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1528-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1529-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1530-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1531-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1532-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1533-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1534-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for us recall (Z-0541-2009)Siemens Microscan2009-02-04