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510(k) K860115

DIGILAB CAMBRIDGE PERIMETER by Bio-Rad — Product Code HOO

K860115 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "DIGILAB CAMBRIDGE PERIMETER". The FDA issued a decision of Substantially Equivalent on February 27, 1986. The device falls under product code HOO (Perimeter, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1986
Date Received
January 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • 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 HOO

  • K941723 — WELCH ALLYN GLAUCOMA DETECTOR (June 6, 1994)
  • K930448 — MARCO PROJECTION PERIMETER (June 21, 1993)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)
  • K864467 — HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (December 15, 1986)
  • K832800 — AUTOMATIC TANGENT SCREEN 50 (September 29, 1983)

FDA data resources