FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDEIA HERPES SIMPLEX VIRUS TEST
K Number: K871877
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
20
Review Days
918
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Basic Information
- Device Name
- IDEIA HERPES SIMPLEX VIRUS TEST
- K Number
- K871877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Date Received
- May 14, 1987
- Decision Date
- November 17, 1989
- Product Code
- LGC
- 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 |
|---|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGC), ordered by most recent decision date.
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MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
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DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
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HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
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THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
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Other Clearances by Boots-Celltech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Mar 12, 1987 | Substantially Equivalent |