QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
FDA 510(k) clearance K894039 · decided 1989-07-14
Clearance details
- K-number
- K894039
- Device name
- QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-06
- Decision date
- 1989-07-14
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- DGO
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Quidel 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 |
|---|---|---|
| IMMULITE(R) ALLERGY FOOD PANEL FP5E (K943194) | Diagnostic Products Corp. | 1995-02-23 |
| IGE EIA TEST KIT (K920087) | The Binding Site, Ltd. | 1992-09-14 |
| ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (K911511) | Diagnostic Products Corp. | 1991-04-17 |
| BECKMAN EPSILON(TM) IGE REAGENT KIT (K893125) | Beckman Instruments, Inc. | 1989-06-16 |
| ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (K872801) | Diagnostic Products Corp. | 1987-09-10 |
| ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM (K860851) | Nichols Institute Diagnostics | 1986-03-28 |
| ALLERG-E IGE ENZYME IMMUNOASSAY KIT (K853607) | Dexall Biomedical Labs, Inc. | 1985-11-07 |
| POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (K831984) | Diagnostic Reagent Tech. | 1983-11-21 |
| EPSILON IGE TEST KIT (K831987) | Beckman Instruments, Inc. | 1983-10-14 |
| LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (K831774) | Diagnostic Reagent Tech. | 1983-07-18 |
| POLYSTYRENE MICROTITER PLATE IMMUNOSORB (K830653) | Diagnostic Reagent Tech. | 1983-04-08 |
| POLYSTYRENE MICROTITER PLATE IMMUNOSOR (K830495) | Diagnostic Reagent Tech. | 1983-04-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |