510(k) K811570
K811570 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "ANTIBODY TO CHLAMYDIA TRACHOMATIS". The FDA issued a decision of Substantially Equivalent on July 23, 1981. The device falls under product code GPW (Antigen, Cf, Psittacosis (Chlamydia Group)), a Class I device regulated under 21 CFR 866.3120. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1981
- Date Received
- June 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, Psittacosis (Chlamydia Group)
- Device Class
- Class I
- Regulation Number
- 866.3120
- Review Panel
- MI
- Submission Type