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510(k) K895967

FASTEC 901 AGGLUTINATION PATTERN READER by Schiff & Co. — Product Code JJQ

K895967 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "FASTEC 901 AGGLUTINATION PATTERN READER". The FDA issued a decision of Substantially Equivalent on October 30, 1989. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Schiff & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1989
Date Received
October 12, 1989
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 Schiff & Co.

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K982136 — JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (March 24, 1999)
  • K981629 — NUTRISAFE ENTERAL FEEDING TUBE (February 4, 1999)
  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K974141 — PLUS REUSABLE RESUSCITATOR (May 21, 1998)
  • K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (October 28, 1996)
  • K955085 — HM-CAP EIA TEST (MODIFICATION) (February 9, 1996)
  • K944159 — HM-CAP EIA KIT (July 18, 1995)
  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)

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