510(k) K801362
K801362 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "ALBUMIN NEPHELOMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1980
- Date Received
- June 9, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nephelometer, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2700
- Review Panel
- CH
- Submission Type