FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SGPT-UV REAGENT SET
K Number: K821206
·
Decision Jul 22, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
21
Review Days
86
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
- SGPT-UV REAGENT SET
- K Number
- K821206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Electronics
- Date Received
- April 27, 1982
- Decision Date
- July 22, 1982
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKA), ordered by most recent decision date.
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE ALT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ALT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRACE REAGENT LINE FOR THE COBAS MIRA
FDA 510(k)
FDA Class 1
·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 |
| 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 |
| K821208 | SGOT-UV 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 |