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510(k) K802408

E-VAC BLOOD CULTURE SYSTEM by Pfizer Pharmaceuticals — Product Code JSC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
October 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type

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  • K771605 — CREATINE KINASE ISOENZYME SUBSTRATE SET (September 15, 1977)
  • K770801 — MICROBIO. PROD. FLUORESCENT ANTIBODY (May 25, 1977)
  • K770425 — NEEDLES, STERILE, AIRWAY (April 15, 1977)

Other clearances for product code JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842849 — TRYPTICASE SOY BROTH (August 3, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841219 — SHOPPED MEAT CARBOHYDRATE (April 4, 1984)
  • K833300 — SABOURAUD BHI AGAR (November 7, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)