FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ANALYTIX AUTO SAMPLE PREP. STA. 1600

K Number: K770210 · Decision Feb 14, 1977
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
56
Review Days
14

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Basic Information

Device Name
ANALYTIX AUTO SAMPLE PREP. STA. 1600
K Number
K770210
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2750
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
G.D. Searle and Co.
Date Received
January 31, 1977
Decision Date
February 14, 1977
Product Code
JQW
Advisory Committee
Clinical Chemistry
Review Advisory Committee
IM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JQW Station, Pipetting And Diluting, For Clinical Use

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K Number Device Name
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K803238 INTRAVASCULAR CATHETER
K810630 SILICONE ELASTOMER COATED LATEX FOLEY
K810131 ADMINISTRATION SET
K802485 SEARLE VASCULAR LOOPS
K801805 METRONIDAZOLE DISCS
K810112 SWR DISPOSABLE PREP RAZOR
K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
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