CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
FDA 510(k) clearance K870369 · decided 1987-08-19
Clearance details
- K-number
- K870369
- Device name
- CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
- Applicant
- Trace Scientific , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-28
- Decision date
- 1987-08-19
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- CIA
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clayton, Vic 3168, AU
- 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 |
|---|---|---|
| CALCIOMETER (K863059) | J. D. Assoc. | 1986-09-26 |
| DSL 1600 (K822898) | Diagnostic Systems Laboratories, Inc. | 1982-12-09 |
| 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.