Atlas FDA

MODIFICATION MIC/API UNISCEPT(R)

FDA 510(k) clearance K884509 · decided 1988-11-22

Clearance details

K-number
K884509
Device name
MODIFICATION MIC/API UNISCEPT(R)
Applicant
Analytical Products, Inc.
Decision
Substantially Equivalent
Date received
1988-10-27
Decision date
1988-11-22
Days to decision
26 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Plainview, NY, US
Third-party review
No
Expedited review
No

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

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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
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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
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010)Analytical Products, Inc.1984-05-04
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009)Analytical Products, Inc.1984-04-24
UNISCEPT(TM) (P830028/S001)Analytical Products, Inc.1984-03-09
UNISCEPT(TM) (P830028)Analytical Products, Inc.1984-03-01
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007)Analytical Products, Inc.1983-11-25
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008)Analytical Products, Inc.1983-11-17
OMNISCEPT(TM) KB SYSTEM (P800029/S005)Analytical Products, Inc.1983-07-05
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S003)Analytical Products, Inc.1982-06-18