510(k) K781009
- Device
- ANALYZER, SERUM IRON & TOTAL IRON BINDIN
- Applicant
- ENVIRONMENTAL SCIENCES ASSOC., INC.
- 510(k) number
- K781009
- Product code
- JMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-27
- Date received
- 1978-06-19
- Regulation
- 862.1275
- Classification name
- Radioimmunoassay, Total Estrogens, Nonpregnancy
- Medical specialty
- Clinical Chemistry
- 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#
- 3007361513
- 1222302
- 2133982
- 2419955
- 3007118747
- 8010132
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K791651 | TOTAL ESTROGENS KIT BY RIA | Radioassay Systems Laboratories, Inc. | 1979-09-27 |
Legacy Summary#
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FDA Review#
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