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510(k) K861946

PTK PLUS. HOME PREGNANCY TEST by Healthcheck Corp. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1986
Date Received
May 20, 1986
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 Healthcheck Corp.

  • K884489 — C&T PREGNANCY TEST KIT (March 8, 1989)
  • K874818 — TENSTAR (September 28, 1988)
  • K881003 — DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 (May 18, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (September 11, 1986)
  • K860287 — PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 (April 28, 1986)
  • K851379 — HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 (April 12, 1985)
  • K850070 — HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 (January 22, 1985)
  • K844281 — PTK HEALTHCHECK PREGNANCY TEST KIT (December 10, 1984)

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