Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hazleton Research Products, Inc. — Predicate Candidate Screening
47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
44 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Hazleton Research Products, Inc. | 1986-06-10 | 18 | 0 |
| K861996 | DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM | Hazleton Research Products, Inc. | 1986-06-09 | 17 | 0 |
| K861887 | MEM GLASGOW POWDERED MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 13 | 0 |
| K861875 | RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861872 | ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861869 | GENTAMICIN-50MG/ML | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861886 | DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 13 | 0 |
| K861873 | MEM GLASGOW MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861867 | MEM ALPHA EAGLE MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861870 | DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861871 | NCTC 109 MEDIUM | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861868 | WILLIAMS MEDIUM E | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861874 | MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER | Hazleton Research Products, Inc. | 1986-05-29 | 14 | 0 |
| K861885 | WILLIAMS MEDIUM E POWDER | Hazleton Research Products, Inc. | 1986-05-29 | 13 | 0 |
| K861810 | CHICKEN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861813 | HUMAN AB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861812 | HUMAN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861815 | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861816 | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861809 | LAMB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861814 | RHESUS MONKEY SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861817 | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K861811 | MOUSE SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | 11 | 0 |
| K850679 | TRYPSIN-EDTA SOLUTION | Hazleton Research Products, Inc. | 1985-03-29 | 36 | 0 |
| K850227 | HAM'S MIXTURE F-12 MEDIUM | Hazleton Research Products, Inc. | 1985-03-11 | 48 | 0 |
| K850228 | HAM'S MIXTURE F-10 MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850218 | SWIM'S S-77 POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850219 | MEM W/SPINNER SALTS POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850220 | ALPHA MEM W/O NUCLEOSIDES POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850235 | BME VITAMINS 100X | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850223 | EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850233 | MEM ESSENTIAL AMINO ACIDS 50X | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850236 | BME AMINO ACIDS 100X | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850234 | H-MEM POWDERED MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850225 | FISCHER'S MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850237 | EBSS W/O CA & MG | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850226 | MCCOY'S MEDIUM 5A, IWAKATA & GRACE MODIFICA- | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850232 | E.MEM POWDERED MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850217 | CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S | Hazleton Research Products, Inc. | 1985-03-07 | 44 | 0 |
| K850222 | HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED- | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K850224 | WAYMOUTH'S MEDIUM MB 752/1 | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K850229 | RPMI-1603 MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K850221 | ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K850231 | ALPHA MEM MEDIUM W/O NUCLEOSIDES | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K850230 | RPMI-1634 MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | 42 | 0 |
| K844877 | HEPES BUFFER IM IN NORMAL SALINE | Hazleton Research Products, Inc. | 1985-02-25 | 70 | 0 |
| K844878 | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG | Hazleton Research Products, Inc. | 1985-02-25 | 70 | 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