510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971157Substantially Equivalent

Macralp(a) Enzyme Immunoassay Kit

Strategic Diagnostics, Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971157 is the FDA 510(k) clearance record for MACRALP(A) ENZYME IMMUNOASSAY KIT, a class I device, cleared for Strategic Diagnostics, Inc. on under FDA product code JHO (Electrophoretic Separation, Lipoproteins). FDA records list one 510(k) clearance for Strategic Diagnostics, Inc. As of , FDA records show no recalls naming K971157.

Clearance record

Decision date
Received
(383 days to decision)
Product code
JHO Electrophoretic Separation, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Strategic Diagnostics, Inc. 128 Sandy Dr., Newark DE
510(k) summary
Statement
Third party review
No

Clearances, product code JHO

Trailing 12 months

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

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