FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYPTOSPORIDIUM ANTIGEN DETECTION
K Number: K905598
·
Decision Sep 5, 1991
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
12
Review Days
266
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Basic Information
- Device Name
- CRYPTOSPORIDIUM ANTIGEN DETECTION
- K Number
- K905598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lmd Laboratories
- Date Received
- December 13, 1990
- Decision Date
- September 5, 1991
- Product Code
- MHJ
- 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 |
|---|---|---|---|
| MHJ | Cryptosporidium Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHJ), ordered by most recent decision date.
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UNI-GOLD CRYPTOSPORIDIUM
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XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
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IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Lmd Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | Jun 7, 1996 | Substantially Equivalent |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | Sep 27, 1995 | Substantially Equivalent |
| K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY | Jun 22, 1995 | Substantially Equivalent |
| K904613 | TRICHINELLA SEROLOGY MICROTITER ELISA | Mar 21, 1991 | Substantially Equivalent |
| K900780 | CYSTICERCOSIS SEROLOGICAL REAGENTS | Oct 4, 1990 | Substantially Equivalent |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Mar 14, 1989 | Substantially Equivalent |
| K883720 | TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA | Jan 24, 1989 | Substantially Equivalent |
| K870318 | AMEBIASIS ELISA TEST KIT | Aug 11, 1987 | Substantially Equivalent |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Nov 12, 1985 | Substantially Equivalent |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Oct 22, 1985 | Substantially Equivalent |