510(k) K873638
K873638 is an FDA 510(k) premarket notification submitted by Ocean Scientific, Inc. for the device "MICRO-CHEM ANALYZER". The FDA issued a decision of Substantially Equivalent on September 29, 1987. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Ocean Scientific, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1987
- Date Received
- September 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2300
- Review Panel
- CH
- Submission Type