510(k) K894389
- Device
- CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
- Applicant
- CATACHEM, INC.
- 510(k) number
- K894389
- Product code
- GGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-12
- Date received
- 1989-07-17
- Regulation
- 864.6160
- Classification name
- Pipette, Sahli
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUIS P LEON
- Address
- 6 N. Pearl St. Port Chester NY US 10573 10573
FDA Registration Numbers#
- 3010131137
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902263 | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION | Trimedyne, Inc. | 1990-07-23 |
Legacy Summary#
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FDA Review#
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