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510(k) K772039

BETA-HCG RIA by Monitor Science Corp. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1977
Date Received
October 28, 1977
Clearance Type
Traditional
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 Monitor Science Corp.

  • K790580 — RIA KIT, PROSTATIC ACID (May 25, 1979)
  • K780949 — BIO-MONITOR AMIKACIN (August 14, 1978)
  • K780950 — BIO-MONITOR TOBRAMYCIN (August 14, 1978)
  • K780951 — BIO-MONITOR GENTAMICIN (August 14, 1978)
  • K772038 — KANAMYCIN RIA (January 12, 1978)

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