Home / 510(k) Clearances / DEN030002

510(k) DEN030002

ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE by Spectral Diagnostics, Inc. — Product Code NGS

DEN030002 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE". The FDA issued a decision of De Novo Granted on June 16, 2003. The device falls under product code NGS (Assay, Endotoxin Activity, Chemiluminescent), a Class II device regulated under 21 CFR 866.3210. Spectral Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 16, 2003
Date Received
April 14, 2003
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Endotoxin Activity, Chemiluminescent
Device Class
Class II
Regulation Number
866.3210
Review Panel
MI
Submission Type

Other clearances by Spectral Diagnostics, Inc.

  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (March 19, 2003)
  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO) (May 24, 2002)
  • K014105 — SPECTRAL'S TROPONIN I (February 1, 2002)
  • K992127 — CARDIOQUANT TROPONIN I TEST (October 4, 1999)
  • K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (June 11, 1999)
  • K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (October 7, 1998)
  • K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (May 7, 1998)
  • K972687 — CARDIAC STATUS CONTROLS/TROPONIN I (July 28, 1997)

Other clearances for product code NGS

  • K183176 — Endotoxin Activity Assay (EAA) (March 12, 2019)

FDA data resources