Home / 510(k) Clearances / K851528

510(k) K851528

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM by Pasco Laboratories, Inc. — Product Code LQM

K851528 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code LQM (Gram Negative Identification Panel), a Class I device regulated under 21 CFR 866.2660. Pasco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Negative Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Pasco Laboratories, Inc.

  • K042331 — PASCO MIC AND MIC/ID PANELS (October 7, 2004)
  • K041776 — PASCO MIC AND MIC/ID PANELS (August 3, 2004)
  • K041214 — PASCO MIC AND MIC/ID PANELS (June 7, 2004)
  • K033119 — PASCO MIC AND MIC/ID PANELS (November 18, 2003)
  • K031727 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (July 30, 2003)
  • K031205 — PASCO MIC AND MIC/ID PANELS (June 13, 2003)
  • K031103 — PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (June 12, 2003)
  • K030933 — PASCO MIC AND MIC/ID PANELS (May 1, 2003)
  • K030620 — PASCO MIC AND MIC/ID PANELS (April 14, 2003)
  • K020331 — PASCO MIC AND MIC/ID PANELS (March 20, 2002)

Other clearances for product code LQM

  • K923313 — ROCHE OXI/FERM II (April 5, 1993)
  • K925915 — VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (March 23, 1993)
  • K912897 — SCEPTOR IDENTIFICATION SYSTEM (October 28, 1991)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 1991)
  • K890057 — SENSITITRE AUTO ID PLATE AP80 (June 9, 1989)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)

FDA data resources