GEMENI IGM ASSAY
FDA 510(k) clearance K800450 · decided 1980-04-24
Clearance details
- K-number
- K800450
- Device name
- GEMENI IGM ASSAY
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-29
- Decision date
- 1980-04-24
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- DAO
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Electro-Nucleonics Laboratories
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 |
|---|---|---|
| ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431) | Roche Diagnostics Corp. | 2004-03-10 |
| SPIFE URINE IFE (K982639) | Helena Laboratories | 1998-11-04 |
| BOEHRINGER MANNHEIM IGM ASSAY (K955908) | Boehringer Mannheim Corp. | 1996-02-09 |
| SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (K850586) | Applications Lab | 1985-03-14 |
| MODIFICATION TO ACS CORONARY GUIDING (K841992) | Advanced Cardiovascular Systems, Inc. | 1984-06-11 |
| IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (K812487) | Dako Corp. | 1981-09-23 |
| ANTISERUM TO HUMAN IGM (K790705) | Kent Laboratories, Inc. | 1979-04-12 |
Recalls involving this device
No recalls on record reference this clearance.