510(k) K770155
- Device
- ALKALINE PHOSPHATASE ISOYZME REAGENT SET
- Applicant
- Gelman Instrument Co.
- 510(k) number
- K770155
- Product code
- CJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-31
- Date received
- 1977-01-24
- Regulation
- 862.1050
- Classification name
- Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- 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#
- 2517506
- 2432235
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CJO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Siemens Healthcare Diagnostics | 2012-08-28 |
| K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | Siemens Healthcare Diagnostics | 2012-07-23 |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1999-01-29 |