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510(k) K982315

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY by Alexon - Trend, Inc. — Product Code LQP

K982315 is an FDA 510(k) premarket notification submitted by Alexon - Trend, Inc. for the device "PROSPECT CAMPYLOBACTER MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code LQP (Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Alexon - Trend, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
July 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Campylobacter Spp.
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Alexon - Trend, Inc.

  • K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (September 3, 1998)
  • K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY (April 23, 1998)

Other clearances for product code LQP

  • K210976 — Curian Campy (December 23, 2021)
  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K191442 — Campylobacter Chek (June 20, 2019)
  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530 (May 28, 2009)
  • K083464 — PREMIER CAMPY, MODEL 618096 (January 30, 2009)
  • K880389 — MERITEC(TM)-CAMPY (JCL) (April 12, 1988)
  • K864027 — BBL CAMPYSLIDE(TM) TEST (December 11, 1986)

FDA data resources