510(k) K933269
K933269 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK(R) PROG ASSAY". The FDA issued a decision of Substantially Equivalent on October 22, 1993. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1993
- Date Received
- July 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Progesterone
- Device Class
- Class I
- Regulation Number
- 862.1620
- Review Panel
- CH
- Submission Type