AVL 988-4 ELECTROLYTE ANALYZER
FDA 510(k) clearance K943702 · decided 1994-09-09
Clearance details
- K-number
- K943702
- Device name
- AVL 988-4 ELECTROLYTE ANALYZER
- Applicant
- Avl Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-29
- Decision date
- 1994-09-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JFP
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Avl Scientific Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230300) | Abbott Point of Care, Inc. | 2023-10-27 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191360) | Abbott Point of Care, Inc. | 2020-02-14 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191626) | Nova Biomedical Corporation | 2019-08-16 |
| EasyLyte Na/K/Cl/Ca Analyzer (K152327) | Medica Corporation | 2016-12-01 |
| AVL OPTI CRITICAL CARE ANALYZER (K984299) | Avl Scientific Corp. | 1998-12-11 |
| AVL 9181 ELECTROLYTE ANALYZER (K972673) | Avl Scientific Corp. | 1997-08-20 |
| EASYLYTE CALCIUM/CHLORIDE ANALYZER (K963694) | Medica Corp. | 1996-11-27 |
| AVL 9180 ELECTROLYTE ANALYZER (K961458) | Avl Scientific Corp. | 1996-06-12 |
| STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (K960120) | Nova Biomedical Corp. | 1996-03-11 |
| EASY LYTE CALCIUM ANALYZER (K943091) | Medica Corp. | 1995-01-17 |
| I-STAT IONIZED CALCIUM TEST (K934642) | I-Stat Corp. | 1993-12-17 |
| ELECTRODE, ION SPECIFIC (K915675) | Alko Diagnostic Corp. | 1992-04-29 |
Recalls involving this device
No recalls on record reference this clearance.