FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
K Number: K897150
·
Decision Feb 26, 1990
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
1
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
- K Number
- K897150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Toyo Jozo Co., Ltd.
- Date Received
- December 26, 1989
- Decision Date
- February 26, 1990
- Product Code
- CHI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHI), ordered by most recent decision date.
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENTINEL LIPASE LIQUID MODEL 17.401B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IL TEST LIPASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIPASE FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIPASE-PS ASSAY PROCEDURE NO. 805
FDA 510(k)
FDA Class 1
·Clinical Chemistry