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510(k) K904782

ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST by Carter Products — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1990
Date Received
October 22, 1990
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

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  • K904273 — MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. (October 31, 1990)
  • K901202 — TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED (June 19, 1990)
  • K901201 — TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED (April 16, 1990)
  • K901190 — TROJANS LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901197 — TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL (April 16, 1990)
  • K901191 — TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901198 — TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED (April 16, 1990)

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