Uni-Cell

FDA 510(k) K823587 · Medical Specialties Laboratories

Substantially Equivalent

510(k) numberK823587

Submission

Device name
Uni-Cell
Applicant
Medical Specialties Laboratories
Mchenry, IL, US
Received
December 6, 1982
Decision date
January 5, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GLQ – Mixture, Control, White-Cell And Red-Cell Indices
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

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K111211Cell-Dyn 22 Plus ControlGLQ · Traditional Streck12/22/2011SE
K110718Cell-Chex with CPPD CrystalsGLQ · Traditional Streck05/26/2011SE
K101335Cell-ChexGLQ · Traditional Streck08/23/2010SE
K090137Stak-Chex Plus ReticsGLQ · Traditional Streck03/18/2009SE
K000945Para 12 Plus ReticsGLQ · Traditional Streck Laboratories, Inc.04/18/2000SE
K994388Xe CheckGLQ · Traditional Streck Laboratories, Inc.01/14/2000SE
K992887Stak-Chex Plus ReticsGLQ · Traditional Streck Laboratories, Inc.11/22/1999SE
K823794Control TM 8GLQ · Traditional General Diagnostics01/14/1983SE
K823498Para 12GLQ · Traditional Streck Laboratories, Inc.12/28/1982SE

More from Streck Laboratories, Inc.

510(k)DeviceDecision
K852643Uni-Plate · Traditional 08/08/1985SE
K844897Hematology Control Uni-Cell 5, Uni-Cell 7 & 8JPK · Traditional 03/22/1985SE
K840114Coagulation Factor Deficient PlasmaGGP · Traditional 02/04/1984SE
K810268NormlceraKIS · Traditional 03/06/1981SE

Questions and answers

When was Uni-Cell cleared by the FDA?

Uni-Cell (K823587) received a 510(k) decision of Substantially Equivalent on January 5, 1983, 30 days after the submission was received.

What is the product code of K823587?

The FDA product code is GLQ – Mixture, Control, White-Cell And Red-Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8625.