CHARACTERIZED FETAL BOVINE SERUM #A-1115— 510(k) K870464

Name: FDA 510(k) clearance K870464
Creator: U.S. Food and Drug Administration
Published: 1987-03-24

Substantially Equivalent

Hyclone Laboratories, Inc.

FDA 510(k) clearance K870464 for CHARACTERIZED FETAL BOVINE SERUM #A-1115, Substantially Equivalent on 1987-03-24. Applicant: Hyclone Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Hyclone Laboratories, Inc.
Product code: Code KIS
Device class: Class 1
Regulation: 21 CFR 864.2800
Advisory panel: Hematology
Date received: 1987-02-03
Decision date: 1987-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIS

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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 Hyclone Laboratories, Inc.

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K884654 — ALPHACALF SERUM1988-11-30
K870938 — FETAL BOVINE SERUM1987-03-31
K870463 — DEFINED FETAL BOVINE SERUM #A-11111987-03-24
K870465 — 6/40 FETAL BOVINE SERUM #A-11101987-03-24
K870466 — DEFINED CALF BOVINE SERUM #A-21111987-03-24

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