DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
FDA 510(k) clearance K864230 · decided 1986-11-28
Clearance details
- K-number
- K864230
- Device name
- DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-28
- Decision date
- 1986-11-28
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- CKE
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wilmington, DE, 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 |
|---|---|---|
| CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (K914167) | Eastman Kodak Company | 1992-03-17 |
| ACID PHOSPHATASE REAGENT SET (K915705) | Tech Intl. Co. | 1992-02-27 |
| ACID PHOSPHATASE TEST (K873726) | King Diagnostics, Inc. | 1988-01-27 |
| ACID PHOSPHATASE REAGENT SET (K860476) | Sterling Diagnostics, Inc. | 1986-03-05 |
| ACID PHOSPHATASE ASSAY KIT (K843380) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-20 |
| ACID PHOSPHATASE REAGENT SET (K821526) | Anco Medical Reagents & Assoc. | 1982-06-10 |
| STANBIO PROSTATIC ACID PHOSPHATASE TEST (K800693) | Stanbio Laboratory | 1980-04-16 |
| DATA-ZYME ACIA PHOSPHATASE PROCEDURE (K790524) | Data Medical Associates, Inc. | 1979-05-23 |
Recalls involving this device
No recalls on record reference this clearance.