510(k) K974009
K974009 is an FDA 510(k) premarket notification submitted by International Newtech Development, Inc. for the device "PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG". The FDA issued a decision of Substantially Equivalent on March 13, 1998. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. International Newtech Development, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1998
- Date Received
- October 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type