510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991362Substantially Equivalent

Hydragel Hemoglobin(e), Mini Hemoglobin(e), 7 Hemoglobin(e), 15 Hemoglobin(e), Acid(e) Hemoglobin(e), Mini Acid(e) Hemo)

Morax, Chelsea MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991362 is the FDA 510(k) clearance record for HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO), a class II device, cleared for Morax on under FDA product code JBD (System, Analysis, Electrophoretic Hemoglobin). FDA records list 11 510(k) clearances for Morax, from to . As of , FDA records show one recall naming K991362.

Clearance record

Decision date
Received
(68 days to decision)
Product code
JBD System, Analysis, Electrophoretic Hemoglobin
Regulation
21 CFR 864.7440
Device class
Class II
Review panel
Hematology
Applicant
Morax 13805 Waterloo Rd., Chelsea MI
510(k) summary
Statement
Third party review
No

Clearances, product code JBD

Trailing 12 months

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

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