FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNO/ASO
K Number: K894780
·
Decision Oct 16, 1989
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
11
Review Days
81
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Basic Information
- Device Name
- IMMUNO/ASO
- K Number
- K894780
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immunostics Co., Inc.
- Date Received
- July 27, 1989
- Decision Date
- October 16, 1989
- Product Code
- GTQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTQ), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
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FDA Class 1
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OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
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TURBIQUANT ASL
FDA 510(k)
FDA Class 1
·Microbiology
BECKMAN ANTI-STREPTOLYSIN O KIT
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FDA Class 1
·Microbiology
ACCUTEX ASO LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Immunostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926569 | IMMUNO RA UNDILUTED | Apr 6, 1993 | Substantially Equivalent |
| K902360 | HEMA-SCREEN | Jul 27, 1990 | Substantially Equivalent |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Sep 28, 1988 | Substantially Equivalent |
| K872910 | IMMUNO/SLE | Aug 12, 1987 | Substantially Equivalent |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Nov 13, 1986 | Substantially Equivalent |
| K854619 | DETECTACULT | Mar 3, 1986 | Substantially Equivalent |
| K853105 | IMMUNO-IM | Sep 3, 1985 | Substantially Equivalent |
| K842110 | SLIDE PREGNANCY TEST | Jul 12, 1984 | Substantially Equivalent |
| K834390 | IMMUNO-CRP | Feb 3, 1984 | Substantially Equivalent |
| K834391 | IMMUNO-RA | Feb 3, 1984 | Substantially Equivalent |