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510(k) K914040

PHOSPHOLIPID REAGENT SET by Sterling Diagnostics, Inc. — Product Code JNT

K914040 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "PHOSPHOLIPID REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 30, 1991. The device falls under product code JNT (Chromatographic, Phospholipids), a Class I device regulated under 21 CFR 862.1575. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
September 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic, Phospholipids
Device Class
Class I
Regulation Number
862.1575
Review Panel
CH
Submission Type

Other clearances by Sterling Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914609 — TRIGLYCERIDES REAGENT SET (November 7, 1991)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)

Other clearances for product code JNT

  • K922792 — ZITHROMAX (July 30, 1992)
  • K792349 — SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (March 12, 1980)

FDA data resources