AMEBIASIS ELISA TEST KIT
FDA 510(k) clearance K870318 · decided 1987-08-11
Clearance details
- K-number
- K870318
- Device name
- AMEBIASIS ELISA TEST KIT
- Applicant
- Lmd Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-01-28
- Decision date
- 1987-08-11
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- KHW
- Device class
- 2
- Regulation number
- 866.3220
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| E. HISTOLYTICA QUIK CHEK (K170728) | Techlab, Inc. | 2017-06-07 |
| E. HISTOLYTICA II (K994101) | Techlab, Inc. | 1999-12-21 |
| E. HISTOLYTICA TEST (K955895) | Techlab, Inc. | 1996-08-30 |
| TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (K954996) | Trend Scientific, Inc. | 1996-08-08 |
| ENTAMOEBA TEST (K944791) | Techlab, Inc. | 1995-03-09 |
| DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA (K900604) | Biovir Laboratories, Inc. | 1990-07-26 |
| GIARDEIA(TM) (K890774) | Antibodies, Inc. | 1989-04-04 |
| GIARDIA STOOL ANTIGEN TEST KIT (K890003) | Lmd Laboratories | 1989-03-14 |
| PROSPECT/GIARDIA (K874849) | Alexon Biomedical, Inc. | 1988-01-05 |
| AMEBIASIS MICROASSAY (K863811) | Diamedix Corp. | 1986-10-09 |
| PDQ AMEBIASIS (K862473) | Diamedix Corp. | 1986-08-01 |
| MEBIASIS AGAR GEL DIFFUSION KIT (K854230) | Lmd Laboratories | 1985-11-12 |
Recalls involving this device
No recalls on record reference this clearance.