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510(k) K791607

BETA-CELL by Biologics Intl., Inc. — Product Code JSG

K791607 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "BETA-CELL". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
August 14, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Biologics Intl., Inc.

  • K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS (August 16, 1988)
  • K823353 — CARCINO-CEK (December 14, 1982)
  • K812060 — BI-ASO SLIDE TEST (August 13, 1981)
  • K811374 — BI-CRP LATEX TEST (June 12, 1981)
  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K800605 — ANA LATEX SLIDE TEST (April 2, 1980)
  • K791609 — BE-SURE (October 2, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources