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510(k) K830397

PEM-C by Health Development Corp. — Product Code JSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
February 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

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  • K791714 — SURGIFEED (January 16, 1980)

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  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)
  • K880111 — CYSTINE TRYPTIC MEDIUM W/SUCROSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)