FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REFEREE BLOOD GAS ANALYZER CONTROLS
K Number: K830181
·
Decision Feb 28, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
57
Review Days
41
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
- REFEREE BLOOD GAS ANALYZER CONTROLS
- K Number
- K830181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Analytical Products, Inc.
- Date Received
- January 18, 1983
- Decision Date
- February 28, 1983
- Product Code
- JJS
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJS), ordered by most recent decision date.
CueSee Hypoxic
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Hematocrit and Metabolite QUALICHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HIGH METABOLITE QUALICHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MISSION CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Analytical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | Mar 11, 1993 | Substantially Equivalent |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | Dec 3, 1992 | Substantially Equivalent |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | Oct 13, 1992 | Substantially Equivalent |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Sep 10, 1990 | Substantially Equivalent |
| K901390 | DMAC INDOLE REAGENT | Apr 16, 1990 | Substantially Equivalent |
| K895796 | API UNISCEPT KB | Nov 13, 1989 | Substantially Equivalent |
| K884510 | MODIFICATION MICRO-MIC | Nov 22, 1988 | Substantially Equivalent |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | Nov 22, 1988 | Substantially Equivalent |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | Mar 23, 1988 | Substantially Equivalent |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | Dec 9, 1987 | Substantially Equivalent |