Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Lakewood Biochemical Co., Inc. · Predicate Candidate Screening

89 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

39 daysmedian FDA review time

45 days90th percentile

89clearances measured

K-number	Device	Applicant	Decided	Review days
K882495	THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007	Lakewood Biochemical Co., Inc.	1988-07-01	15
K882351	MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181	Lakewood Biochemical Co., Inc.	1988-06-28	21
K882463	POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421	Lakewood Biochemical Co., Inc.	1988-06-22	7
K882182	SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326	Lakewood Biochemical Co., Inc.	1988-06-06	13
K880946	NUTRIENT GELATIN - PRODUCT NUMBER T2860	Lakewood Biochemical Co., Inc.	1988-04-01	25
K880947	NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE	Lakewood Biochemical Co., Inc.	1988-04-01	25
K880945	CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597	Lakewood Biochemical Co., Inc.	1988-03-30	23
K875136	COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750	Lakewood Biochemical Co., Inc.	1988-01-12	28
K874537	KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR	Lakewood Biochemical Co., Inc.	1987-11-20	17
K874538	TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516	Lakewood Biochemical Co., Inc.	1987-11-20	17
K874344	QUAD PLATE (4 DIFFERENT MEDIA)	Lakewood Biochemical Co., Inc.	1987-11-06	17
K874345	TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050	Lakewood Biochemical Co., Inc.	1987-11-06	17
K873951	MICRO CULTURE MEDIA P3528, P3137, P3149, P3139	Lakewood Biochemical Co., Inc.	1987-10-23	25
K873952	MICRO CULTURE MEDIA P3141, P3136, P3148, P3748	Lakewood Biochemical Co., Inc.	1987-10-23	25
K873975	PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323	Lakewood Biochemical Co., Inc.	1987-10-23	24
K873479	COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873480	TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873481	HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873482	TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873483	TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020	Lakewood Biochemical Co., Inc.	1987-10-08	42
K873827	MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)	Lakewood Biochemical Co., Inc.	1987-10-08	17
K873411	SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084	Lakewood Biochemical Co., Inc.	1987-10-06	43
K873412	GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038	Lakewood Biochemical Co., Inc.	1987-10-06	43
K873413	GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR	Lakewood Biochemical Co., Inc.	1987-10-06	43
K873828	CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990	Lakewood Biochemical Co., Inc.	1987-10-06	15
K873323	SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873324	SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873325	SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873326	SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873327	SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873328	SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252	Lakewood Biochemical Co., Inc.	1987-10-02	45
K873329	HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330	Lakewood Biochemical Co., Inc.	1987-10-02	43
K873703	LYSINE IRON AGAR (LIA) PRODUCT #T3046	Lakewood Biochemical Co., Inc.	1987-10-02	18
K873704	MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053	Lakewood Biochemical Co., Inc.	1987-10-02	18
K873318	SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873319	SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873320	SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873321	SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873322	SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873216	BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873217	BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873218	BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873219	BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873220	BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873221	BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873222	BRAIN HEART INFUSION BROTH W/X AND V - #T4540	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873223	MACCONKEY AGAR - PRODUCT #P1606	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873224	BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873225	EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309	Lakewood Biochemical Co., Inc.	1987-09-23	40
K873226	XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601	Lakewood Biochemical Co., Inc.	1987-09-23	40

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