BETA-CELL— 510(k) K791607

Name: FDA 510(k) clearance K791607
Creator: U.S. Food and Drug Administration
Published: 1979-09-24

Substantially Equivalent

Biologics Intl., Inc.

FDA 510(k) clearance K791607 for BETA-CELL, Substantially Equivalent on 1979-09-24. Applicant: Biologics Intl., Inc.. Device class: 1.

Clearance details

Applicant: Biologics Intl., Inc.
Product code: Code JSG
Device class: Class 1
Regulation: 21 CFR 866.2300
Advisory panel: Microbiology
Date received: 1979-08-14
Decision date: 1979-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K881523 — DEXTROSE TRYPTONE BROTH1988-04-18
K881525 — COOKED MEAT MEDIUM1988-04-18
K881528 — CASEIN PEPTONE, LOW VITAMIN1988-04-18

More clearances from Biologics Intl., Inc.

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K882229 — AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS1988-08-16
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K812060 — BI-ASO SLIDE TEST1981-08-13
K811374 — BI-CRP LATEX TEST1981-06-12
K811375 — BI-RA SLIDE TEST1981-06-12

Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.