Home / 510(k) Clearances / K942361

510(k) K942361

WHITSOFT by Biowhittaker Molecular Applications, Inc. — Product Code JJQ

K942361 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "WHITSOFT". The FDA issued a decision of Substantially Equivalent on April 4, 1995. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1995
Date Received
May 17, 1994
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

Other clearances by Biowhittaker Molecular Applications, Inc.

  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)
  • K942250 — BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (April 4, 1995)
  • K942245 — BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (April 3, 1995)
  • K925209 — MUMPS STAT (October 14, 1994)
  • K935618 — SPECIMEN TRANSPORT MEDIUM (April 21, 1994)
  • K932679 — RHEUMELISA II HISTONE ANTIBODY TEST KIT (August 23, 1993)
  • K930757 — RHEUMELISA II JO-1 ANTIBODY TEST KIT (March 26, 1993)
  • K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT (March 23, 1993)
  • K920753 — RF STAT IGM TEST KIT (March 30, 1992)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources