FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TURBIQUANT ASL
K Number: K915742
·
Decision Jun 28, 1993
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
36
Applicant Total
145
Review Days
553
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Basic Information
- Device Name
- TURBIQUANT ASL
- K Number
- K915742
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- December 23, 1991
- Decision Date
- June 28, 1993
- 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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BECKMAN ANTI-STREPTOLYSIN O KIT
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ACCUTEX ASO LATEX TEST
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TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
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BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Behring Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | Oct 27, 1997 | Substantially Equivalent |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Oct 20, 1997 | Substantially Equivalent |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Oct 17, 1997 | Substantially Equivalent |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Sep 12, 1997 | Substantially Equivalent |
| K972316 | OPUS D-DIMER | Sep 9, 1997 | Substantially Equivalent |
| K972116 | VON WILLEBRAND REAGENT | Jul 25, 1997 | Substantially Equivalent |
| K972011 | OPUS ETHANOL | Jul 22, 1997 | Substantially Equivalent |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | Jun 25, 1997 | Substantially Equivalent |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Jun 25, 1997 | Substantially Equivalent |
| K964595 | OPUS PSA TEST SYSTEM | Jun 24, 1997 | Substantially Equivalent |