Marion Laboratories, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Marion Laboratories, Inc.” (first 1978, latest 1989), across 26 product codes in 7 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 3 | 3 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 2 | 2 |
| JTS | Stains, Microbiologic | 2 | 2 |
| JTW | System, Transport, Aerobic | 2 | 2 |
| JXA | Kit, Screening, Urine | 2 | 2 |
| KEQ | Media, Mounting, Water Soluble | 2 | 2 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 2 | 2 |
| KZJ | Device, Gas Generating | 2 | 2 |
| LJF | Device, Antimicrobial Drug Removal | 2 | 2 |
| NAD | Dressing, Wound, Occlusive | 2 | 2 |
Plus 16 more product codes.
Review panels
- Microbiology (17)
- General and Plastic Surgery (6)
- Pathology (5)
- Clinical Toxicology (5)
- Anesthesiology (1)
- Hematology (1)
- Physical Medicine (1)
Most recent Marion Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | NAD | 1989-03-23 | 226 |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | DKE | 1988-07-05 | 201 |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | — | 1988-05-27 | 162 |
| K874554 | ENVICLUSIVE (TM) | NAD | 1988-03-11 | 128 |
| K874552 | ENVISAN PAD | KOZ | 1988-01-22 | 79 |
| K874551 | ENVINET(TM) | EFQ | 1988-01-22 | 79 |
| K874553 | ENVISAN PASTE | KOZ | 1987-12-18 | 44 |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | LLH | 1987-04-14 | 42 |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | LLH | 1986-09-17 | 8 |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | KZJ | 1986-06-16 | 13 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marion Laboratories, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Marion Health & Safety, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Marion Laboratories, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Marion Laboratories, Inc.” (first 1978, latest 1989), across 26 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Marion Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marion Laboratories, Inc. is 45 days.
Which FDA product codes appear under Marion Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are LLH (Reagents, Clostridium Difficile Toxin, 3); DKE (Reagents, Test, Tetrahydrocannabinol, 2); JTS (Stains, Microbiologic, 2).
Next steps
- See all 38 Marion Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLH, Marion Laboratories, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.