Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dutchland Laboratories, Inc. — Predicate Candidate Screening
75 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
20 daysmedian FDA review time
51 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821918 | POWDERED RPMI-1603 MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821915 | BME AUTOCLAVABLE MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821912 | MCCOY'S POWDER MEDIUM 5A SUSPENSION | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821914 | COON'S F-12 POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821911 | S-MEM-JOKLIK'S POWDER | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821913 | ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821916 | IMPROVED MEM-RICHTER'S POWDER MODIF. | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821919 | POWDERED RPMI-1634 MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K821917 | WAYMOUTH'S POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | 29 | 0 |
| K820922 | HAMS F-10 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820919 | EARLE'S-199 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820931 | HANK'S 199 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820925 | H - BME POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820921 | D-MEM-LOW GLUCOSE-POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820915 | MEM AUTOCLAVABLE MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820928 | EBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820923 | DULBECCO'S PBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820916 | D-MEM-HIGH GLUCOSE-POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820914 | EMEM POWERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820920 | MCCOY'S 5A POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820917 | L-15 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820930 | FISCHER'S POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820918 | HMEM POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820926 | E-BME POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820924 | HAMS F-12 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820927 | HBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820929 | RPMI-164POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820509 | MEM VITAMINS (100X | Dutchland Laboratories, Inc. | 1982-04-08 | 44 | 0 |
| K820495 | SODIUM PYRUVATE (100MM) | Dutchland Laboratories, Inc. | 1982-03-26 | 31 | 0 |
| K820508 | MEM NON-ESSENTIAL AMINO ACIDS (100X) | Dutchland Laboratories, Inc. | 1982-03-26 | 31 | 0 |
| K813513 | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | Dutchland Laboratories, Inc. | 1981-12-31 | 16 | 0 |
| K813512 | RHESUS MONKEY BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-12-29 | 14 | 0 |
| K812885 | DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM | Dutchland Laboratories, Inc. | 1981-11-24 | 41 | 0 |
| K812602 | RABBIT COAGULASE PLASMA | Dutchland Laboratories, Inc. | 1981-09-29 | 14 | 0 |
| K812522 | RABBIT COMPLEMENT | Dutchland Laboratories, Inc. | 1981-09-23 | 21 | 0 |
| K812368 | RAT BLOOD IN ALSEVER'S, CITRATED | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812374 | ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812376 | SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812367 | GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812373 | RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812365 | PARA 1 SENDAI HEMAGGLUTININ | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812375 | BABY CHICK BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812372 | GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF | Dutchland Laboratories, Inc. | 1981-09-09 | 20 | 0 |
| K812384 | NEWBORN CALF SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812385 | NATAL CALF (BOVINE) SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812371 | HEMOLYSIN | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812381 | DONOR HORSE SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812370 | GUINEA PIG COMPLEMENT REGULAR | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812383 | CALF (BOVINE) SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
| K812386 | FETAL BOVINE SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda