BOEHRINGER MANNHEIM IGM ASSAY
FDA 510(k) clearance K955908 · decided 1996-02-09
Clearance details
- K-number
- K955908
- Device name
- BOEHRINGER MANNHEIM IGM ASSAY
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-29
- Decision date
- 1996-02-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DAO
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| 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 |
| GEMENI IGM ASSAY (K800450) | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 |
| ANTISERUM TO HUMAN IGM (K790705) | Kent Laboratories, Inc. | 1979-04-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |