QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
FDA 510(k) clearance K961544 · decided 1996-09-24
Clearance details
- K-number
- K961544
- Device name
- QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
- Applicant
- Consolidated Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-22
- Decision date
- 1996-09-24
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- DGR
- Device class
- 1
- Regulation number
- 866.5700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Austin, TX, 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 |
|---|---|---|
| PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (K902220) | Boehringer Mannheim Corp. | 1990-09-05 |
| LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014) | Bio-Rad | 1987-01-09 |
| RADIOASSAY, CONTROL SERUM I, II, III (K790298) | Kallestad Laboratories, Inc. | 1979-04-04 |
| ICS NORMAL CONTROL SERUM (K781355) | Beckman Instruments, Inc. | 1978-08-31 |
Recalls involving this device
No recalls on record reference this clearance.