FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URICAR
K Number: K812700
·
Decision Nov 5, 1981
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
52
Review Days
43
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Basic Information
- Device Name
- URICAR
- K Number
- K812700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hi Chem, Inc.
- Date Received
- September 23, 1981
- Decision Date
- November 5, 1981
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNK), ordered by most recent decision date.
URIC ACID MODEL 3P39
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OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
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VITALAB URIC ACID REAGENT
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ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
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URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Hi Chem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | Apr 4, 1996 | Substantially Equivalent |
| K951818 | HICHEM ALT REAGENT KIT | May 15, 1995 | Substantially Equivalent |
| K943684 | HICHEM ENZYME VERIFIER KIT | Oct 4, 1994 | Substantially Equivalent |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | May 13, 1994 | Substantially Equivalent |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | Jul 17, 1990 | Substantially Equivalent |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | Oct 24, 1986 | Substantially Equivalent |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Jun 13, 1986 | Substantially Equivalent |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Jun 5, 1986 | Substantially Equivalent |
| K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) | May 29, 1986 | Substantially Equivalent |
| K861284 | AP REAGENT CARTRIDGE | Apr 28, 1986 | Substantially Equivalent |