510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823498Substantially Equivalent

Para 12

Streck Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823498 is the FDA 510(k) clearance record for PARA 12, a class II device, cleared for Streck Laboratories, Inc. on under FDA product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices). FDA records list 70 510(k) clearances for Streck Laboratories, Inc., from to . As of , FDA records show no recalls naming K823498.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GLQ Mixture, Control, White-Cell And Red-Cell Indices
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Streck Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GLQ

Trailing 12 months

FDA records hold no clearances under product code GLQ in the trailing twelve months.

FDA records show no clearances under product code GLQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GLQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260