510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800780Substantially Equivalent

Sandare Lyophilized Hemoglobin Controls

Sandare Chemical Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800780 is the FDA 510(k) clearance record for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS, a class II device, cleared for Sandare Chemical Co., Inc. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 23 510(k) clearances for Sandare Chemical Co., Inc., from to . As of , FDA records show no recalls naming K800780.

Clearance record

Decision date
Received
(16 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Sandare Chemical Co., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

FDA records show no clearances under product code JPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JPK, 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