Atlas FDA

SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES

FDA 510(k) clearance K936305 · decided 1995-07-13

Clearance details

K-number
K936305
Device name
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
Applicant
Radiometer America, Inc.
Decision
Substantially Equivalent
Date received
1993-12-21
Decision date
1995-07-13
Days to decision
569 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Westlake, OH, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Radiometer America

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
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST recall (Z-0327-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST recall (Z-0328-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST recall (Z-0329-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST recall (Z-0330-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST recall (Z-0331-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST recall (Z-0332-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST recall (Z-0333-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST recall (Z-0334-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST recall (Z-0335-2023)Remel Inc2022-12-08

PMA approvals by this applicant

RecordFirmDate
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004)Radiometer America, Inc.1986-02-21
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003)Radiometer America, Inc.1985-02-22
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002)Radiometer America, Inc.1984-03-01
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001)Radiometer America, Inc.1981-09-21