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510(k) K802408

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

K802408 is an FDA 510(k) premarket notification submitted by Pfizer Pharmaceuticals for the device "E-VAC BLOOD CULTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Pfizer Pharmaceuticals has at least 5 other 510(k) clearances on record.

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

Other clearances by Pfizer Pharmaceuticals

  • K885321 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (March 22, 1989)
  • K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (March 31, 1981)
  • 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)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)

FDA data resources