Atlas FDA

AMMONIA/IRON STANDARD KIT

FDA 510(k) clearance K972333 · decided 1997-07-23

Clearance details

K-number
K972333
Device name
AMMONIA/IRON STANDARD KIT
Applicant
Verichem Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1997-06-23
Decision date
1997-07-23
Days to decision
30 days
Clearance type
Traditional
Product code
JIX
Device class
2
Regulation number
862.1150
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Providence, RI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials recall (Z-0743-2007)Mega Diagnostics2007-04-14
Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood recall (Z-1543-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL. recall (Z-1546-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1. recall (Z-1547-06)Pointe Scientific, Inc.2006-09-30
Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2. recall (Z-1548-06)Pointe Scientific, Inc.2006-09-30