510(k) K863059
- Device
- CALCIOMETER
- Applicant
- J. D. ASSOC.
- 510(k) number
- K863059
- Product code
- CIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-26
- Date received
- 1986-08-12
- Regulation
- 862.1145
- Classification name
- Methylthymol Blue, Calcium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DI PIETRO
- Address
- 163 Montclair Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Trace Scientific , Ltd. | 1987-08-19 |
| K822898 | DSL 1600 | Diagnostic Systems Laboratories, Inc. | 1982-12-09 |
| K792396 | ELVI CALCIUM | Volu Sol Medical Industries | 1979-12-06 |
| K771468 | MULTISTAT III CALCIUM TEST | Instrumentation Laboratory CO | 1977-09-12 |
Legacy Summary#
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FDA Review#
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