AVL OMNI ANALYZER
FDA 510(k) clearance K945915 · decided 1995-04-05
Clearance details
- K-number
- K945915
- Device name
- AVL OMNI ANALYZER
- Applicant
- Avl Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-02
- Decision date
- 1995-04-05
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- JJC
- Device class
- 1
- Regulation number
- 862.2150
- 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 |
|---|---|---|
| NOVA 16 ANALYZER (K945584) | Nova Biomedical Corp. | 1995-02-08 |
| OPERA SYSTEM (K943376) | Miles, Inc. | 1994-09-14 |
| TECHNICON RA-2000(TM) SYSTEM (K901410) | Technicon Instruments Corp. | 1990-07-17 |
| PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (K901141) | Baxter Healthcare Corp | 1990-04-09 |
| RFA/2 RAPID FLOW ANALYZER W/COMPUTER (K890332) | Alpkem Corp. | 1989-02-17 |
| AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (K881056) | American Research Products Co. | 1988-11-15 |
| TECHNICON SMAC 3 SYSTEM (K875105) | Technicon Instruments Corp. | 1988-02-16 |
| TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998) | Technicon Instruments Corp. | 1987-05-26 |
| TECHNICON RA-XT SYSTEM WITH ANALYTES (K862561) | Technicon Instruments Corp. | 1986-10-20 |
| TECHNICON RA-500 SYSTEM (K854345) | Technicon Instruments Corp. | 1985-11-26 |
| REPLACEMENT REAGENTS FOR SMAC II SYSTEMS (K852306) | Methodist Hospital of Memphis | 1985-08-02 |
| LANCER ANALYZER CUPS (K833157) | Sherwood Medical Co. | 1983-12-08 |