Lmd Laboratories: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Lmd Laboratories” (first 1984, latest 1996), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 178 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 5 | 5 |
| MHJ | Cryptosporidium Spp. | 2 | 2 |
| GMZ | Antigens, All Types, Escherichia Coli | 1 | 1 |
| GPG | Antigen, Latex Agglutination, Trichinella Spiralis | 1 | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 | 1 |
| MDJ | Reagents, Cysticercosis | 1 | 1 |
| MHI | Giardia Spp. | 1 | 1 |
Review panels
- Microbiology (12)
Most recent Lmd Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | MHJ | 1996-06-07 | 199 |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | GMZ | 1995-09-27 | 476 |
| K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY | MHI | 1995-06-22 | 262 |
| K905598 | CRYPTOSPORIDIUM ANTIGEN DETECTION | MHJ | 1991-09-05 | 266 |
| K904613 | TRICHINELLA SEROLOGY MICROTITER ELISA | GPG | 1991-03-21 | 161 |
| K900780 | CYSTICERCOSIS SEROLOGICAL REAGENTS | MDJ | 1990-10-04 | 226 |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | KHW | 1989-03-14 | 70 |
| K883720 | TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA | LGD | 1989-01-24 | 146 |
| K870318 | AMEBIASIS ELISA TEST KIT | KHW | 1987-08-11 | 195 |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | KHW | 1985-11-12 | 22 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lmd Laboratories.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lmd Laboratories?
FDA lists 12 510(k) clearances under the applicant name “Lmd Laboratories” (first 1984, latest 1996), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lmd Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lmd Laboratories is 178 days.
Which FDA product codes appear under Lmd Laboratories?
The most frequent FDA product codes under this applicant name are KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., 5); MHJ (Cryptosporidium Spp., 2); GMZ (Antigens, All Types, Escherichia Coli, 1).
Next steps
- See all 12 Lmd Laboratories clearances with predicates and recalls
- Run predicate analysis for product code KHW, Lmd Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.