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510(k) K923951

CD8 CYTOSPHERES KIT by Coulter Electronics, Inc. — Product Code MAM

K923951 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "CD8 CYTOSPHERES KIT". The FDA issued a decision of Substantially Equivalent on April 25, 1994. The device falls under product code MAM (Dna-Probe, B And T Lymphocyte), a Class II device regulated under 21 CFR 864.5220. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1994
Date Received
August 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Probe, B And T Lymphocyte
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Coulter Electronics, Inc.

  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K922704 — COULTER MAXM W/ AUTOLOADER (July 27, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)
  • K905767 — COULTER DART ALT (GPT) REAGENT (January 25, 1991)

FDA data resources