NATAL CALF (BOVINE) SERUM - STERILE— 510(k) K812385

Name: FDA 510(k) clearance K812385
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Dutchland Laboratories, Inc.

FDA 510(k) clearance K812385 for NATAL CALF (BOVINE) SERUM - STERILE, Substantially Equivalent on 1981-09-08. Applicant: Dutchland Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dutchland Laboratories, Inc.
Product code: Code KIS
Device class: Class 1
Regulation: 21 CFR 864.2800
Advisory panel: Hematology
Date received: 1981-08-20
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIS

view all

K881287 — ANIMAL AND HUMAN SERA1988-04-05
K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-21591988-04-04
K880470 — BOVINE CALF SERUM CATALOG #A-21191988-04-01
K872847 — SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT1987-08-10
K870580 — MLC NORMAL SERUM1987-04-08

More clearances from Dutchland Laboratories, Inc.

view all

K821911 — S-MEM-JOKLIK'S POWDER1982-07-27
K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION1982-07-27
K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM1982-07-27
K821914 — COON'S F-12 POWDER MEDIUM1982-07-27
K821915 — BME AUTOCLAVABLE MEDIUM1982-07-27

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