KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
FDA 510(k) clearance K934273 · decided 1994-03-21
Clearance details
- K-number
- K934273
- Device name
- KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1993-08-31
- Decision date
- 1994-03-21
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- DMT
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eastman Kodak Company
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410) | Beckman Coulter, Inc. | 2000-04-10 |
| SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (K971506) | Beckman Instruments, Inc. | 1997-06-03 |
| ETHYL ALCOHOL ASSAY (K923783) | Diagnostic Reagents, Inc. | 1993-01-21 |
| EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (K864894) | Em Diagnostic Systems, Inc. | 1987-01-09 |
| ETHYL ALCOHOL ASSAY KIT (K843378) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-14 |
| EMIT-ST SERUM ETHYL ALCOHOL ASSAY (K810467) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL ASSAY (K802621) | Syva Co. | 1980-10-31 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Sl recall (Z-0295-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |