510(k) K914906

AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT by Bio-Tek Instruments, Inc. — Product Code JJQ

K914906 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
November 1, 1991
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