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510(k) K780305

CELL by Dynatech Laboratories, Inc. — Product Code KJF

K780305 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "CELL". The FDA issued a decision of Substantially Equivalent on March 27, 1978. The device falls under product code KJF (System, Suspension, Cell Culture), a Class I device regulated under 21 CFR 864.2240. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1978
Date Received
February 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suspension, Cell Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances by Dynatech Laboratories, Inc.

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K943701 — MRX MICROPLATE READER (October 20, 1994)
  • K923456 — MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (October 13, 1992)
  • K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (May 4, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)
  • K913590 — MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (October 25, 1991)
  • K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (October 17, 1989)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)

Other clearances for product code KJF

  • K893787 — LIFECELL RECOVERY CONTAINER (June 23, 1989)
  • K892645 — AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY (June 13, 1989)
  • K875221 — TOOTH PRESERVING SYSTEM (April 14, 1988)

FDA data resources