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510(k) K922590

BIO-PEN SRK II CALCULATOR by Bio-Rad — Product Code LQB

K922590 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-PEN SRK II CALCULATOR". The FDA issued a decision of Substantially Equivalent on August 3, 1993. The device falls under product code LQB (Medical Computers And Software For Ophthalmic Use), a Class III device. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1993
Date Received
June 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Computers And Software For Ophthalmic Use
Device Class
Class III
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Bio-Rad

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  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code LQB

  • K860205 — BIO-PEN CALCULATOR (April 24, 1986)

FDA data resources