DSL 1600
FDA 510(k) clearance K822898 · decided 1982-12-09
Clearance details
- K-number
- K822898
- Device name
- DSL 1600
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-29
- Decision date
- 1982-12-09
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- CIA
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (K870369) | Trace Scientific , Ltd. | 1987-08-19 |
| CALCIOMETER (K863059) | J. D. Assoc. | 1986-09-26 |
| ELVI CALCIUM (K792396) | Volu Sol Medical Industries | 1979-12-06 |
| MULTISTAT III CALCIUM TEST (K771468) | Instrumentation Laboratory CO | 1977-09-12 |
Recalls involving this device
No recalls on record reference this clearance.