FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SGOT-UV REAGENT SET
K Number: K821208
·
Decision Jul 20, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
21
Review Days
84
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
- SGOT-UV REAGENT SET
- K Number
- K821208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Electronics
- Date Received
- April 27, 1982
- Decision Date
- July 20, 1982
- Product Code
- CIT
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIT), ordered by most recent decision date.
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVATED ASPARTATE AMINOTRANSFERASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COBAS C 111 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Omega Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K823691 | PHOSPHORUS REAGENT SET | Jan 7, 1983 | Substantially Equivalent |
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821206 | SGPT-UV REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821212 | UREA NITROGEN REAGENT SET | Jul 22, 1982 | Substantially Equivalent |
| K821201 | LDH-UV REAGENT SET | Jul 20, 1982 | Substantially Equivalent |
| K821205 | TRIGLYCERIDE REAGENT SET | Jul 20, 1982 | Substantially Equivalent |
| K821207 | SGPT REAGENT SET | Jul 14, 1982 | Substantially Equivalent |
| K821209 | SGOT REAGENT SET | Jul 14, 1982 | Substantially Equivalent |
| K821199 | CREATININE REAGENT SET | Jul 13, 1982 | Substantially Equivalent |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | Jul 13, 1982 | Substantially Equivalent |