Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JSJ — Predicate Candidate Screening
307 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
60 days90th percentile
307clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Lakewood Biochemical Co., Inc. | 1988-06-22 | 7 | 0 |
| K881570 | SABOURAUD MALTOSE AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881571 | YM BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881526 | CHAPMAN STONE MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881573 | PHYTONE YEAST EXTRACT AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881578 | STREPTOSEL | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881565 | INHIBITORY MOLD AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881547 | MITIS SALIVARIUS AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881561 | TERGITOL 7 BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881544 | LITTMAN AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881574 | W-L DIFFERENTIAL MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881524 | DERMATOPHYTE TEST MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | Hardy Media | 1988-03-31 | 85 | 0 |
| K880123 | LOWENSTEIN-JENSEN SLANT | Hardy Media | 1988-03-31 | 85 | 0 |
| K880137 | BHI WITH C & C SLANT | Hardy Media | 1988-03-30 | 84 | 0 |
| K880140 | BCYE AGAR | Hardy Media | 1988-03-30 | 84 | 0 |
| K880128 | SABOURAUD DEXTROSE AGAR W/CHLORO | Hardy Media | 1988-03-30 | 84 | 0 |
| K880945 | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 | Lakewood Biochemical Co., Inc. | 1988-03-30 | 23 | 0 |
| K880141 | BCYE, SELECTIVE (W/MPA) | Hardy Media | 1988-03-30 | 84 | 0 |
| K880136 | CETRIMIDE SELECTIVE AGAR | Hardy Media | 1988-03-30 | 84 | 0 |
| K880716 | SLIDE CULTURE PLATE-POTATO FLAKE AGAR | Remel Co. | 1988-03-03 | 9 | 0 |
| K880717 | SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR | Remel Co. | 1988-03-03 | 9 | 0 |
| K874176 | BIOTIS (TM) HAEMOPHILUS DUCREYI | Otisville Biopharm, Inc. | 1988-02-05 | 115 | 0 |
| K874178 | BIOTIS (TM) BCYE SELECTIVE | Otisville Biopharm, Inc. | 1987-12-04 | 52 | 0 |
| K874345 | TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 | Lakewood Biochemical Co., Inc. | 1987-11-06 | 17 | 0 |
| K874173 | BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI | Otisville Biopharm, Inc. | 1987-10-28 | 15 | 0 |
| K874172 | BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) | Otisville Biopharm, Inc. | 1987-10-28 | 15 | 0 |
| K873951 | MICRO CULTURE MEDIA P3528, P3137, P3149, P3139 | Lakewood Biochemical Co., Inc. | 1987-10-23 | 25 | 0 |
| K873975 | PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323 | Lakewood Biochemical Co., Inc. | 1987-10-23 | 24 | 0 |
| K873479 | COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206 | Lakewood Biochemical Co., Inc. | 1987-10-08 | 42 | 0 |
| K873827 | MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C) | Lakewood Biochemical Co., Inc. | 1987-10-08 | 17 | 0 |
| K873412 | GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038 | Lakewood Biochemical Co., Inc. | 1987-10-06 | 43 | 0 |
| K873326 | SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080 | Lakewood Biochemical Co., Inc. | 1987-10-02 | 45 | 0 |
| K873327 | SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330 | Lakewood Biochemical Co., Inc. | 1987-10-02 | 45 | 0 |
| K873323 | SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412 | Lakewood Biochemical Co., Inc. | 1987-10-02 | 45 | 0 |
| K873318 | SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL | Lakewood Biochemical Co., Inc. | 1987-09-29 | 42 | 0 |
| K873322 | SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088 | Lakewood Biochemical Co., Inc. | 1987-09-29 | 42 | 0 |
| K873319 | SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE | Lakewood Biochemical Co., Inc. | 1987-09-29 | 42 | 0 |
| K873224 | BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772 | Lakewood Biochemical Co., Inc. | 1987-09-23 | 40 | 0 |
| K873216 | BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C | Lakewood Biochemical Co., Inc. | 1987-09-23 | 40 | 0 |
| K873241 | BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873234 | BRAIN HEART INFUSION AGAR W/C&C - PRODUCT #P3407 | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873239 | BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463 | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873242 | BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873238 | BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450 | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873233 | BRAIN HEART INFUS AGAR W/5% SB & CHLORAMPHENICOL | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873237 | BRAIN HEART INFUS AGAR SLANT W/6% SB CHLORAMPHENIC | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 0 |
| K873244 | BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP | Lakewood Biochemical Co., Inc. | 1987-09-22 | 39 | 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