QUALITY CONTROL MATERIAL (ASSAYED)
FDA 510(k) clearance K935819 · decided 1994-03-22
Clearance details
- K-number
- K935819
- Device name
- QUALITY CONTROL MATERIAL (ASSAYED)
- Applicant
- Columbia Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-03
- Decision date
- 1994-03-22
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- DKC
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Springfield, VA, 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 |
|---|---|---|
| MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (K031392) | Medical Analysis Systems, Inc. | 2003-07-01 |
| AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 (K933425) | Sigma Diagnostics, Inc. | 1993-11-16 |
| BECKMAN CX AMMONIA/ALCOHOL CONTROL (K934467) | Beckman-Diagnostic Systems Group | 1993-10-27 |
| ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III (K932067) | Sigma Diagnostics, Inc. | 1993-06-16 |
| SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (K912827) | Cala Diagnostics | 1991-08-12 |
| WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826) | Cala Diagnostics | 1991-07-26 |
| ETHANOL CONTROLS LOW & HIGH E5133/E5258 (K843872) | Sigma Chemical Co. | 1984-10-31 |
| TOXI CHEM SERUM ALCOHOL CONTROL (K833514) | Fisher Diagnostics | 1983-12-08 |
| EMIT-ST ETHYL ALCOHOL SERUM CONTROLS (K810465) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL URINE CONTROLS (K802618) | Syva Co. | 1980-10-31 |
Recalls involving this device
No recalls on record reference this clearance.