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510(k) K820149

PYR BROTH by Carr-Scarborough Microbiologicals, Inc. — Product Code JSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 19, 1982
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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  • K905472 — LAP DISCS (February 27, 1991)
  • K905666 — M. CAT. BUTYRATE DISC (February 26, 1991)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (February 6, 1986)
  • K860302 — PYR DISCS (February 5, 1986)

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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)