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510(k) K993140

WATER FOR TISSUE CULTURE, MODELS 1500 by Conception Technologies — Product Code MTW

K993140 is an FDA 510(k) premarket notification submitted by Conception Technologies for the device "WATER FOR TISSUE CULTURE, MODELS 1500". The FDA issued a decision of Substantially Equivalent on August 2, 2000. The device falls under product code MTW (System, Water, Reproduction, Assisted, And Purification), a Class II device regulated under 21 CFR 884.6170. Conception Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2000
Date Received
September 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Water, Reproduction, Assisted, And Purification
Device Class
Class II
Regulation Number
884.6170
Review Panel
OB
Submission Type

Other clearances by Conception Technologies

  • K030850 — ENHANCE HUMAN SERUM ALBUMIN (April 8, 2003)
  • K023655 — ENHANCE HTF MEDIUM WITH HEPES (December 13, 2002)
  • K023717 — SPERM WASH MEDIUM WITH GENTAMICIN (December 13, 2002)
  • K020490 — PBS, PBSW WITH CATIONS AND PHENOL RED (March 28, 2002)
  • K011481 — 10% PVP; 10% PVP IN EBSS SOLUTION (July 2, 2001)
  • K011573 — HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM (July 2, 2001)
  • K011462 — OIL FOR TISSUE CULTURE (June 13, 2001)

Other clearances for product code MTW

  • K011598 — WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE (June 13, 2001)

FDA data resources