510(k) K801849
K801849 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "LACTI-QUANT". The FDA issued a decision of Substantially Equivalent on Sep 16, 1980. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 1980
- Date Received
- Aug 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Prolactin (Lactogen)
- Device Class
- Class I
- Regulation Number
- 862.1625
- Review Panel
- CH
- Submission Type
- 510(k) Exempt