510(k) K894486
- Device
- QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
- Applicant
- BIOKIT USA, INC.
- 510(k) number
- K894486
- Product code
- GTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-24
- Date received
- 1989-07-18
- Regulation
- 866.3720
- Classification name
- Antistreptolysin - Titer/streptolysin O Reagent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ODRIOZOLA
- Address
- Can Male Llissa D'Amunt Barcelona ES 08186 08186
FDA Registration Numbers#
- 2084025
- 1645225
- 9610806
- 9680746
- 2050012
- 3005333358
- 3003741796
- 2432235
- 3012963943
- 2250051
- 1641328
- 1832216
- 1319808
- 1649661
- 8040374
- 1000403749
- 2250030
- 2517506
- 1827821
- 9610746
- 3004493545
- 3002642396
- 2050010
- 3012471076
- 2085064
- 3003871639
- 3014325803
- 1616487
- 9610126
- 2029372
- 1319681
- 3003601075
- 3021841051
- 3000308930
- 3017379203
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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