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510(k) K844281

PTK HEALTHCHECK PREGNANCY TEST KIT by Healthcheck Corp. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1984
Date Received
November 5, 1984
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)
  • K861946 — PTK PLUS. HOME PREGNANCY TEST (June 16, 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)

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