510(k) K781009
K781009 is an FDA 510(k) premarket notification submitted by Environmental Sciences Assoc., Inc. for the device "ANALYZER, SERUM IRON & TOTAL IRON BINDIN". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code JMD (Radioimmunoassay, Total Estrogens, Nonpregnancy), a Class I device regulated under 21 CFR 862.1275. Environmental Sciences Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1978
- Date Received
- June 19, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Total Estrogens, Nonpregnancy
- Device Class
- Class I
- Regulation Number
- 862.1275
- Review Panel
- CH
- Submission Type