Atlas FDA

ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER

FDA 510(k) clearance K900887 · decided 1990-05-15

Clearance details

K-number
K900887
Device name
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1990-02-26
Decision date
1990-05-15
Days to decision
78 days
Clearance type
Traditional
Product code
CGZ
Device class
2
Regulation number
862.1170
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032)Abbott Laboratories2026-05-11
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068)Abbott Laboratories2026-02-23
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056)Abbott Laboratories2026-02-12
ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067)Abbott Laboratories2026-02-12
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031)Abbott Laboratories2026-02-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03