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510(k) K823587

UNI-CELL by Medical Specialties Laboratories — Product Code GLQ

K823587 is an FDA 510(k) premarket notification submitted by Medical Specialties Laboratories for the device "UNI-CELL". The FDA issued a decision of Substantially Equivalent on January 5, 1983. 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. Medical Specialties Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
December 6, 1982
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 Medical Specialties Laboratories

  • K852643 — UNI-PLATE (August 8, 1985)
  • K844897 — HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 (March 22, 1985)
  • K840114 — COAGULATION FACTOR DEFICIENT PLASMA (February 4, 1984)
  • K810268 — NORMLCERA (March 6, 1981)

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)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)
  • K994388 — XE CHECK (January 14, 2000)
  • K992887 — STAK-CHEX PLUS RETICS (November 22, 1999)
  • K823794 — CONTROL TM 8 (January 14, 1983)
  • K823498 — PARA 12 (December 28, 1982)

FDA data resources