510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN030002Unknown

Endotoxin Activity Assay (Eaa) Device

Spectral Diagnostics, Inc., Rockville MD / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN030002 is the FDA 510(k) clearance record for ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE, a class II device, cleared for Spectral Diagnostics, Inc. on under FDA product code NGS (Assay, Endotoxin Activity, Chemiluminescent). FDA records list 12 510(k) clearances for Spectral Diagnostics, Inc., from to . As of , FDA records show no recalls naming DEN030002.

Clearance record

Decision date
Received
(63 days to decision)
Product code
NGS Assay, Endotoxin Activity, Chemiluminescent
Regulation
21 CFR 866.3210
Device class
Class II
Review panel
Microbiology
Applicant
Spectral Diagnostics, Inc. 16809 Briardale Rd., Rockville MD
Third party review
No

Clearances, product code NGS

Trailing 12 months

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

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