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510(k) K011550

HCG STAT PAK ULTRA-FAST by Chembio Diagnostic Systems, Inc. — Product Code JHI

K011550 is an FDA 510(k) premarket notification submitted by Chembio Diagnostic Systems, Inc. for the device "HCG STAT PAK ULTRA-FAST". The FDA issued a decision of Substantially Equivalent on August 14, 2001. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Chembio Diagnostic Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2001
Date Received
May 18, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Chembio Diagnostic Systems, Inc.

  • K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (June 3, 2020)
  • K011551 — SURE CHECK PREGNANCY TEST (August 14, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (February 12, 1999)
  • K961965 — SURE CHECK PREGNANCY TEST (June 24, 1996)
  • K923925 — HCG STAT-PAK (December 24, 1992)

Other clearances for product code JHI

  • K241919 — Innovita HCG Pregnancy Rapid Combo Test (August 2, 2024)
  • K203272 — Alltest Pregnancy Rapid Combo Test Cassette (January 31, 2022)
  • K172322 — Atellica IM Total hCG (ThCG) (March 29, 2018)
  • K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu (December 22, 2017)
  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (February 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H (May 30, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)

FDA data resources