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510(k) K180771

Acro HCG Pregnancy Rapid Test by Acro Biotech, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
March 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Acro Biotech, Inc.

  • K172512 — ACRO HCG Pregnancy Rapid Test (February 2, 2018)
  • K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (August 7, 2006)
  • K060354 — ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (July 28, 2006)
  • K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 (June 15, 2006)
  • K053034 — ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 (June 6, 2006)
  • K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (June 6, 2006)
  • K053035 — ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (May 5, 2006)
  • K060353 — ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 (May 3, 2006)
  • K053032 — ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (February 9, 2006)

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