510(k) K831603
- Device
- TITAN GE/IEPLATE
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K831603
- Product code
- JZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-07
- Date received
- 1983-05-18
- Regulation
- 866.4900
- Classification name
- Support Gels
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010162800
- 3014317667
- 1226143
- 8022890
- 1618982
- 3026844237
- 8020869
- 3009605026
- 3011852752
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940037 | I.D. AND SEAKEM GTG AGAROSES | Fmc Corp. | 1995-02-24 |
Legacy Summary#
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FDA Review#
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