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510(k) K000945

PARA 12 PLUS RETICS by Streck Laboratories, Inc. — Product Code GLQ

K000945 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "PARA 12 PLUS RETICS". The FDA issued a decision of Substantially Equivalent on April 18, 2000. The device falls under product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices), a Class II device regulated under 21 CFR 864.8625. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2000
Date Received
March 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Control, White-Cell And Red-Cell Indices
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Streck Laboratories, Inc.

  • K042587 — RETIC-CHEX FOR CELL-DYN (October 19, 2004)
  • K040107 — CYTO-CHEX BCT (July 27, 2004)
  • K040025 — A1C-CELLULAR (March 2, 2004)
  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K021922 — MODIFICATION TO PARA 5X (June 25, 2002)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K011410 — PARA 5X (June 26, 2001)
  • K001443 — SUGAR CHEX ONE (June 29, 2000)
  • K000115 — RETIC CHEX LINEARITY (March 27, 2000)

Other clearances for product code GLQ

  • K111211 — CELL-DYN 22 PLUS CONTROL (December 22, 2011)
  • K110718 — CELL-CHEX WITH CPPD CRYSTALS (May 26, 2011)
  • K101335 — CELL-CHEX (August 23, 2010)
  • K090137 — STAK-CHEX PLUS RETICS (March 18, 2009)
  • K994388 — XE CHECK (January 14, 2000)
  • K992887 — STAK-CHEX PLUS RETICS (November 22, 1999)
  • K823794 — CONTROL TM 8 (January 14, 1983)
  • K823587 — UNI-CELL (January 5, 1983)
  • K823498 — PARA 12 (December 28, 1982)

FDA data resources