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510(k) K020694

QAB2A IGM ELISA KIT by Cheshire Diagnostics , Ltd. — Product Code MVS

K020694 is an FDA 510(k) premarket notification submitted by Cheshire Diagnostics , Ltd. for the device "QAB2A IGM ELISA KIT". The FDA issued a decision of Substantially Equivalent on April 19, 2002. The device falls under product code MVS (Kit, Typing, Hla-Dqb), a Class II device regulated under 21 CFR 866.5660. Cheshire Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
March 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Typing, Hla-Dqb
Device Class
Class II
Regulation Number
866.5660
Review Panel
HE
Submission Type

Other clearances by Cheshire Diagnostics , Ltd.

  • K021610 — QAB2A IGM ELISA KIT HRP (July 12, 2002)
  • K021611 — QAB2A IGG ELISA KIT HRP (July 12, 2002)
  • K021192 — QACA IGG/IGM ELISA KIT HRP (May 16, 2002)
  • K020695 — QAB2A IGG ELISA KIT (April 19, 2002)
  • K020241 — QACA IGG/IGM ELISA KIT (March 13, 2002)

FDA data resources