510(k) K771468
- Device
- MULTISTAT III CALCIUM TEST
- Applicant
- Instrumentation Laboratory CO
- 510(k) number
- K771468
- Product code
- CIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-12
- Date received
- 1977-08-04
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K863059 | CALCIOMETER | J. D. Assoc. | 1986-09-26 |
| K822898 | DSL 1600 | Diagnostic Systems Laboratories, Inc. | 1982-12-09 |
| K792396 | ELVI CALCIUM | Volu Sol Medical Industries | 1979-12-06 |