510(k) K913590

MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER by Dynatech Laboratories, Inc. — Product Code JJQ

K913590 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER". The FDA issued a decision of Substantially Equivalent on October 25, 1991. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
August 12, 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