Atlas FDA

PICCOLO(TM)

FDA 510(k) clearance K942782 · decided 1995-03-13

Clearance details

K-number
K942782
Device name
PICCOLO(TM)
Applicant
Abaxis, Inc.
Decision
Substantially Equivalent
Date received
1994-06-13
Decision date
1995-03-13
Days to decision
273 days
Clearance type
Traditional
Product code
JJG
Device class
1
Regulation number
862.2140
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973)Instrumentation Laboratory CO1987-06-11
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838)Beckman Instruments, Inc.1987-05-26
ANALYST PHYSICIAN'S OFFICE PROFILER (K854523)E.I. Dupont DE Nemours & Co., Inc.1986-01-08
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Recalls involving this device

RecordFirmDate
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo recall (Z-1155-2010)Abaxis Inc2010-03-16