Perkinelmer Life Sciences, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Perkinelmer Life Sciences, Inc.” (first 2002, latest 2002), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 171 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 |
|---|---|---|---|
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 | 1 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 1 | 0 |
Review panels
Most recent Perkinelmer Life Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021541 | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | JNB | 2002-10-28 | 171 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN040002 | De Novo | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | 2004-08-24 |
Recalls
11 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2017-08-02.
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.
- Perkinelmer, Inc. (15 510(k)s)
- Perkinelmer Optoelectronics (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perkinelmer Life Sciences, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Perkinelmer Life Sciences, Inc.” (first 2002, latest 2002), plus 1 De Novo decision, across 2 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 Perkinelmer Life Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perkinelmer Life Sciences, Inc. is 171 days.
Which FDA product codes appear under Perkinelmer Life Sciences, Inc.?
The most frequent FDA product codes under this applicant name are JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, 1); NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry, 1).
Next steps
- See all 1 Perkinelmer Life Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JNB, Perkinelmer Life Sciences, 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, 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.