IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
FDA 510(k) clearance K964781 · decided 1997-05-09
Clearance details
- K-number
- K964781
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-27
- Decision date
- 1997-05-09
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- DDS
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, CA, 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 |
|---|---|---|
| RAICHEM PREALBUMIN SPIA (K972812) | Hemagen Diagnostics, Inc. | 1997-08-28 |
| 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.