SPQ PAL CONTROL LEVEL II
FDA 510(k) clearance K934966 · decided 1994-01-11
Clearance details
- K-number
- K934966
- Device name
- SPQ PAL CONTROL LEVEL II
- Applicant
- Incstar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-15
- Decision date
- 1994-01-11
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DDS
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Stillwater, MN, 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 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781) | Beckman Instruments, Inc. | 1997-05-09 |
| ICS PAB PREALBUMIN REAGENT TEST KIT (K854811) | Beckman Instruments, Inc. | 1986-01-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003) | Incstar Corp. | 1993-07-23 |
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002) | Incstar Corp. | 1991-03-28 |
| GAMMA DAB (125I) AFP RIA KIT (P790032/S001) | Incstar Corp. | 1986-08-22 |
| GAMMA DAB (125I) AFP RIA KIT (P790032) | Incstar Corp. | 1986-04-30 |