510(k) K801089

J.T. BAKER NEPHELOMETER by J.T. Baker Chemical Co. — Product Code JQX

K801089 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "J.T. BAKER NEPHELOMETER". The FDA issued a decision of Substantially Equivalent on May 28, 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
May 28, 1980
Date Received
May 8, 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