Home / 510(k) Clearances / K961515

510(k) K961515

QUANTASE PHENYLALANINE ASSAY by Shield Diagnostics, Ltd. — Product Code JNB

K961515 is an FDA 510(k) premarket notification submitted by Shield Diagnostics, Ltd. for the device "QUANTASE PHENYLALANINE ASSAY". The FDA issued a decision of Substantially Equivalent on June 12, 1996. The device falls under product code JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine), a Class II device regulated under 21 CFR 862.1555. Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1996
Date Received
April 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device Class
Class II
Regulation Number
862.1555
Review Panel
CH
Submission Type

Other clearances by Shield Diagnostics, Ltd.

  • K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (April 17, 2000)
  • K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (October 15, 1998)
  • K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (August 21, 1998)
  • K972981 — SHIELD HELICO-G2 ELISA KIT (March 17, 1998)
  • K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (November 15, 1996)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K955303 — DIASTAT ANTI-CARDIOLIPIN KIT (May 30, 1996)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)
  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)
  • K943630 — DIASTAT ANTI-MPO (PANCA) KIT (March 6, 1995)

Other clearances for product code JNB

  • K021541 — NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (October 28, 2002)
  • K003584 — NEOLYNX SCREENING APPLICATION MANAGER (March 19, 2001)
  • K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT (June 19, 2000)
  • K984463 — QUANTASE PHE/GAL SCREENING ASSAY (February 16, 1999)
  • K982307 — WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (February 2, 1999)
  • K974047 — ACCUWELL PHENYLALANINE ASSAY (December 5, 1997)
  • K963040 — MANUAL PHENYLALANINE TEST (October 1, 1996)
  • K960437 — RADIAS PHENYLALANINE TEST (August 16, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)

FDA data resources