RAICHEM PREALBUMIN SPIA
FDA 510(k) clearance K972812 · decided 1997-08-28
Clearance details
- K-number
- K972812
- Device name
- RAICHEM PREALBUMIN SPIA
- Applicant
- Hemagen Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-28
- Decision date
- 1997-08-28
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- DDS
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781) | Beckman Instruments, Inc. | 1997-05-09 |
| SPQ PAL CONTROL LEVEL II (K934966) | Incstar Corp. | 1994-01-11 |
| ICS PAB PREALBUMIN REAGENT TEST KIT (K854811) | Beckman Instruments, Inc. | 1986-01-24 |
Recalls involving this device
No recalls on record reference this clearance.