Atlas FDA

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK

FDA 510(k) clearance K910886 · decided 1991-06-17

Clearance details

K-number
K910886
Device name
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
Applicant
Kallestad Diag, A Div. of Erbamont, Inc.
Decision
Substantially Equivalent
Date received
1991-03-04
Decision date
1991-06-17
Days to decision
105 days
Clearance type
Traditional
Product code
GTQ
Device class
1
Regulation number
866.3720
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Chaska, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645)Ortho-Clinical Diagnostics2005-12-14
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (K953437)Olympus America, Inc.1995-10-20
TURBIQUANT ASL (K915742)Behring Diagnostics, Inc.1993-06-28
BECKMAN ANTI-STREPTOLYSIN O KIT (K926236)Beckman Instruments, Inc.1993-06-15
ACCUTEX ASO LATEX TEST (K924247)J.S. Medical Assoc.1992-12-07
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723)Simplicity Diagnostics, Inc.1992-09-18
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (K915053)Beckman Instruments, Inc.1992-03-19
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150)Beckman Instruments, Inc.1991-07-17
CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416)Biotrax, Inc.1991-06-24
QM300 CALIBRATOR G PACK (K910885)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
QM300 CONTROL G PACK (K910887)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
TARGET ASO TEST (K910073)Texas Immunology, Inc.1991-05-21

Recalls involving this device

No recalls on record reference this clearance.