FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K Number: K854081
·
Decision Jan 3, 1986
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
31
Applicant Total
20
Review Days
88
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Basic Information
- Device Name
- IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
- K Number
- K854081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Date Received
- October 7, 1985
- Decision Date
- January 3, 1986
- Product Code
- GQG
- 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 |
|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | FDA class 1 | Microbiology |
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Other Clearances by Boots-Celltech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | Nov 17, 1989 | Substantially Equivalent |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | Dec 8, 1988 | Substantially Equivalent |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | Apr 18, 1988 | Substantially Equivalent |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | Mar 24, 1988 | Substantially Equivalent |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Feb 24, 1988 | Substantially Equivalent |
| K872843 | OVEIA (TM) DUAL ANALYTE | Feb 2, 1988 | Substantially Equivalent |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | Oct 20, 1987 | Substantially Equivalent |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | Jun 15, 1987 | Substantially Equivalent |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | May 8, 1987 | Substantially Equivalent |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Apr 20, 1987 | Substantially Equivalent |