510(k) K935819
- Device
- QUALITY CONTROL MATERIAL (ASSAYED)
- Applicant
- COLUMBIA DIAGNOSTICS, INC.
- 510(k) number
- K935819
- Product code
- DKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-22
- Date received
- 1993-12-03
- Regulation
- 862.3280
- Classification name
- Alcohol Control Materials
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STANLEY P GOLDENBERG
- Address
- 8001 Research Way Springfield VA US 22153 22153
FDA Registration Numbers#
- 2020952
- 3010939897
- 3003951180
- 2030861
- 2050010
- 2085064
- 3003610499
- 2050012
- 3005333358
- 1827821
Source Documents#
Other 510(k) Records For Product Code DKC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 |
| K933425 | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | Sigma Diagnostics, Inc. | 1993-11-16 |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Beckman-Diagnostic Systems Group | 1993-10-27 |
| K932067 | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | Sigma Diagnostics, Inc. | 1993-06-16 |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Cala Diagnostics | 1991-08-12 |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Cala Diagnostics | 1991-07-26 |
| K843872 | ETHANOL CONTROLS LOW & HIGH E5133/E5258 | Sigma Chemical Co. | 1984-10-31 |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | Fisher Diagnostics | 1983-12-08 |
| K810465 | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS | Syva Co. | 1981-03-06 |
| K802618 | EMIT-STM ETHYL ALCOHOL URINE CONTROLS | Syva Co. | 1980-10-31 |
Legacy Summary#
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FDA Review#
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